Laparoskopie vs Laparotomie in der Gynäkologie Univ. Prof. Dr. Dr. h.c. Heinz Kölbl Klinische...

Laparoskopie vs Laparotomie in der GynäkologieUniv. Prof. Dr. Dr. h.c. Heinz KölblKlinische Abteilung für allgemeine

Gynäkologie und gynäkologische OnkologieUniversitätsklinik für Frauenheilkunde Wien

International Advisory Board Astellas

International Advisory Board Pfizer

Female Pelvic Health and Urology J&J

AMS

Laparoskopie vs Laparotomie

• Allgemeine Gynäkologie– Eingriffe an den Adnexen

• benigne Tumore– schwangere Frauen– nicht schwangere Frauen

– Myome– Hysterektomie

• Onkologie

• Urogynäkologie

Laparoscopy versus laparotomy for benign ovarian tumor

Cochrane Database of Systematic Reviews. 11, 2010

Laparoscopy versus laparotomy for benign ovarian tumour.Cochrane Database of Systematic Reviews. 11, 2010

• Objectives – To determine the benefits, harms, and costs of laparoscopic

surgery compared with laparotomy or minilaparotomy in women with ovarian tumours assumed to be benign

• Types of studies – All randomised controlled trials (RCTs) which compared

laparoscopic surgery with laparotomy or minilaparotomy as a treatment for ovarian tumours assumed to be benign


• Types of participants

– Inclusion criteria

• We considered three groups of women – with benign ovarian tumours who were treated surgically

by either laparoscopy, minilaparotomy, or laparotomy» those with any type of benign ovarian tumour » those with dermoid cysts» those with endometriomata




• We only included trials where women were investigated in the preoperative setting with transvaginal or transabdominal ultrasonography, or both, for analysis of the morphological scoring in order to exclude from the trial women with tumours that were likely to be malignant.




• We noted whether trials reported: – (1) the use of colour Doppler transvaginal

ultrasonography to assess vascular quality from the vascular resistance index (RI) and pulsatility index (PI);

– (2) preoperative estimation of serum CA 125 levels, levels greater than 35 U/ml were suggestive of malignancy.



– Exclusion criteria

• (1) Women with ovarian tumours having features suggestive of malignancy, determined during preoperative assessment.

• (2) Women with gynaecological cancer. • (3) Trials where the author did not describe the

preoperative assessment that was performed.


• Types of interventions – Two surgical approaches used for the management of ovarian

tumours assumed to be benign were compared: • laparoscopy and laparotomy.

• Laparotomy was further defined as either ‚– standard laparotomy' with a Pfannanstiel incision or – 'minilaparotomy', where the transverse incision was 3 to 7 cm

long.


• Types of outcome measures

– The major outcome measures were as follows.

– 1 Surgical • Mean duration of surgery • Change of diagnosis from benign to malignant tumour

– 2 Adverse events Surgical injury of the:• bladder • ureter • vasculature • small bowel • colon


• 3 Postoperative complications – Requirement for blood transfusion

– Haematoma

– Fever

– Incision infection

– Urinary tract infection

– Thromboembolism

– Perioperative mortality

• 4 Any other adverse event– Urinary retention

– Chemical peritonitis

– Intestinal obstruction


• 5 Any other adverse events of surgery – either surgical injury, – postoperative complications,– other adverse events of surgery

• 6 Short-term outcomes – Pain: VAS scores – Pain: pain free at 24 to 48 hrs postoperation – Pain: requirement for analgesia – Length of hospital stay – Recurrence rate after 6 to 12 months – Blood loss determined by haemoglobin level

• 7 Economic measure – Direct cost of surgical procedures


• Results– Description of studies

• Initially 32 studies were identified which compared laparoscopy and laparotomy for benign ovarian tumours. Twenty of these studies were excluded because they were not randomised

• Twelve randomised controlled trials that were published between 1995 and 2007 met the inclusion criteria for this review

• The six additional primary studies in this update were RCTs


• Results

– Effects of interventions

• Included studies

– Twelve studies and 769 patients were included in this review.

– Nine studies compared laparoscopy and laparotomy– Three studies compared laparoscopy and

minilaparotomy


• Results Laparoscopy vs Laparotomy– Surgical outcomes (a) Duration of surgery

• (i) In the studies of any type of benign ovarian tumour there was considerable heterogeneity in the estimates and it was inappropriate to pool the data

• (ii) In the subgroup of dermoid cysts there was substantial inconsistency making it inappropriate to pool the data (Chi2 = 7.67, P = 0.02, I2 = 74%)

• (iii) In the subgroup of ovarian endometriomata there were no statistically significant differences between treatments arms for duration of surgery


• Results Surgical outcome (b) Diagnosis of malignant tumour

– In one study, the ovarian tumours in four women were found to be malignant after frozen section was performed during laparoscopy, with subsequent conversion to laparotomy


• Results Adverse events

– (a) Surgical injury

• Nine studies provided data for analysis of surgical injuries


• Results Adverse events – (a) Surgical injury

• (i) In the subgroup of any type of benign ovarian tumour no injuries to the ureter, small bowel, or colon were reported. One study reported a single case of bladder injury in the laparotomy group and two studies each reported a single case of vascular injury in the laparoscopy group.

• (ii) In the subgroup of dermoid cysts no surgical injuries were reported.

• (iii) In the subgroup of ovarian endometriomata no surgical injuries were reported.



– (b) Postoperative complications

• (i) In the subgroup of any type of benign ovarian tumour in four studies there was a decreased risk of fever in the laparoscopy group

• There was a non-statistically significant difference between laparoscopy and laparotomy regarding the risk of incision infection and urinary tract infection

• There was also a decreased risk of urinary retention in the laparoscopy group in the one trial that reported this outcome and blood loss measured by haemoglobin levels




• (ii) In the dermoid cyst subgroup one study only reported a single case of fever in the laparotomy group There were no reported cases of incision infection or urinary tract infection in this study but this may be because all patients received prophylactic antibiotics




• (iii) In the subgroup of ovarian endometriomata: no postoperative complications were reported.

• The pooled estimate for fever, including the subgroups of any type of benign ovarian tumour and dermoid cysts, showed a reduced odds of febrile morbidity associated with laparoscopy.


• Results Adverse events (c) Any adverse events of surgery (surgical injury, postoperative complications, and any other adverse events of

surgery)

– The pooled estimate for total number of adverse events including the subgroups of any type of benign ovarian tumour or dermoid cysts showed a lower odds for any adverse event with laparoscopy compared to laparotomy.


• Results Adverse events Short-term outcomes (a) Postoperative pain (VAS scores, free of pain at 24 to 48 hrs aft her surgery,

requirement for analgesia)

– The odds for being free of pain were significantly greater for laparoscopy in each of the three subgroups.


• Results Adverse events (b) Recurrence of ovarian tumours six to 12 months after surgery

– Recurrence was mentioned in only two studies with a combined total of 108 participants

– Two cases of recurrence occurred in the group with any type of benign ovarian tumour


• Results Adverse events (c) Length of hospital stay

– The pooled estimate for these three subgroups favoured laparoscopy with heterogeneity and inconsistency detected.


• Results Economic measures (a) Direct costs of surgical procedures

– Using a cost analysis from a social perspective, the total costs of laparoscopy were significantly lower when compared to laparotomy.


• Results Laparoscopy versus minilaparotomy – Surgical outcomes

– Adverse events – Short-term outcomes


• Discussion– The results of 12 randomised controlled trials (N = 769 women) showed

that laparoscopic surgery was associated with significantly less postoperative pain, fewer adverse events of surgery (surgical injury or postoperative complications), and a shorter length of stay in hospital.

– Although duration of hospital stay was significantly reduced, by nearly three days, after laparoscopy when compared to laparotomy significant heterogeneity was detected.

– Cost is another factor that should be taken into consideration when choosing the surgical approach .The costs of laparoscopy compared to laparotomy were reported by one trial with limited sample size, with only 34 patients in each group.


• Discussion

– Overall frequency of inadvertent rupture of the cysts during operation was larger in the laparoscopy group that in the minilaparotomy group.

– In patients with unrecognised neoplasms, laparoscopy may be associated with an increase in the rate of intraperitoneal spillage with consequent dissemination of tumour cells and advances in disease stage.

– Thus, we would suggest that careful preoperative examination, as undertaken in these studies, decreases the risk of a malignancy being identified during a laparoscopy procedure.


• Discussion

– This review is limited in its ability to guide surgical practice because of the small number of women randomised in the 12 studies.

– The small number of randomised studies may be the result of surgeons' resistance to accept this type of study design since only 39% of all treatments validated in surgery are from randomised studies.

Laparoscopic surgery for presumed benign ovarian tumor during pregnancy

The Cochrane Database of Systematic Reviews Issue: Volume (4), 2009

Laparoscopic surgery for presumed benign ovarian tumor during pregnancy The Cochrane Database of Systematic Reviews Issue: Volume (4), 2009

• A small number of women have tumors of the ovaries diagnosed during pregnancy.

• Most of these tumors are not malignant, and if they are small then treatment can be left until after the birth.

• In case of suspected malignant ovarian tumor, the laparoscopic surgery should be avoided due to the risk of port site metastasis and inadequate surgical staging.

• The serous cystadenoma and dermoid cyst are the two most common pathologies found.


• Ovarian tumor in pregnancy requiring surgical intervention has an incidence ranging from 0.0004% to 0.36%.

• However, if the tumour is larger that 6 cm in diameter, it is suggested that it is better to operate and remove them during pregnancy

• The surgical management of ovarian tumors in pregnancy is similar to that of non-pregnant women.

• The procedure can be done by open surgery (laparotomy) or keyhole surgery (laparoscopy) technique.


• There were no randomized controlled trials identified that compared the effects of using laparoscopic surgery for benign ovarian tumor during pregnancy on maternal and fetal health and the use of healthcare resources.

• There are risks and benefits for both laparoscopic surgery and laparotomy in pregnancy, current sources of information are limited to only case series reports


• The benefits of laparoscopic surgery include shorter hospital stay, earlier return to normal activity, and reduced postoperative pain

• However, conventional laparoscopic surgery techniques required the infusion of gas carbon dioxide in the peritoneum to distend the abdomen and displace the bowel upward to create the room for surgical manipulation.

• Serious complications such as hypercarbia and perforation of internal organs have also been reported.


• An animal study reported decreased uterine blood flow from using the gas carbon dioxide pneumoperitoneum.

• To confirm the safety of laparoscopic treatment for benign ovarian tumour during pregnancy, there is a need for methodologically rigorous studies to provide direct evidence about the relative benefits and harms of and for laparoscopic surgery for benign ovarian tumor compared to laparotomy in pregnancy.

• This information is best obtained from randomized controlled trials.

Minimally invasive surgical techniques versus open myomectomy for uterine fibroids

Cochrane Database of Systematic Reviews. 4,2012

Publication Type: Protocol

Techniques and instrumentation

A multicenter randomized, controlled studycomparing laparoscopic versus minilaparotomic myomectomy: short-term outcomes

Stefano Palomba, M.D.a, Errico Zupi, M.D.b, Tiziana Russo, M.D.a, Angela Falbo, M.D.a, Daniela Marconi, M.D.b, Achille Tolino, M.D.c, Francesco Manguso, M.D.d, Alberto Mattei, M.D.e, Fulvio Zullo, M.D.aa Department of Obstetrics & Gynecology, University “Magna Graecia” of Catanzaro, Catanzaro, Italyb Department of Obstetrics & Gynecology, University “Tor Vergata” of Rome, Rome, Italyc Department of Obstetrics & Gynecology, University “Federico II” of Naples, Naples, Italyd Department of Clinical and Experimental Medicine, University “Federico II” of Naples, Naples, Italye Department of Obstetrics & Gynecology, University of Florence, Florence, Italy

Fertility Sterility 2007 Oct;88(4):942-51

A multicenter randomized, controlled studycomparing laparoscopic versus minilaparotomic myomectomy: short-term outcomesFertility Sterility 2007 Oct;88(4):942-51.

• DESIGN: Randomized controlled trial

• PATIENT(S): One hundred thirty-six women wishing to conceive and candidate for myomectomy due to symptomatic uterine leiomyomas or unexplained infertility.

• INTERVENTION(S): Myomectomy through laparoscopic or minilaparotomic access.

A multicenter randomized, controlled studycomparing laparoscopic versus minilaparotomic myomectomy: short-term outcomesFertility Sterility 2007 Oct;88(4):942-51

• RESULT(S): – Leiomyoma enucleation and hysterotomy suturing times were

significantly shorter after minilaparotomic myomectomy

– the degree of surgical difficulty was significantly higher for the laparoscopic myomectomy

– Intraoperative blood loss, variation in hemoglobin levels, quantity of pain control drugs used postoperatively, and hospitalization were significantly lower in the laparoscopic group than in the minilaparotomic one

A multicenter randomized, controlled studycomparing laparoscopic versus minilaparotomic myomectomy: short-term outcomesFertility Sterility 2007 Oct;88(4):942-51

• RESULT(S): Surgical outcomes were significantly influenced by specific investigational centers involved, and by leiomyoma dimensions and localizations. This last variable is the strongest predictor of surgical outcome.

• CONCLUSION(S):....... A careful evaluation of the dimensions and localizations of fibroids are needed to address to the right choice to the best approach.

Surgical approach to hysterectomy for benign gynaecological disease

Cochrane Database of Systematic Reviews Issue: Volume (12), 2010

Surgical approach to hysterectomy for benign gynaecological disease Cochrane Database of Systematic Reviews Issue: Volume (12), 2010

• The three approaches to hysterectomy for benign disease are abdominal hysterectomy (AH), vaginal hysterectomy (VH), and laparoscopic hysterectomy (LH).

• Only randomised controlled trials comparing one surgical approach to hysterectomy with another were included. There were 34 studies with 4495 women included.


Results

– The benefits of VH versus AH

• were speedier return to normal activities (mean difference (MD) 9.5 days),

• fewer febrile episodes or unspecified infections,

• and shorter duration of hospital stay (MD 1.1 days).


• Results

– The benefits of LH versus AH • were speedier return to normal activities (MD 13.6 days), • lower intraoperative blood loss (MD 45 cc), • a smaller drop in haemoglobin (MD 0.55 g/dl), • shorter hospital stay (MD 2.0 days), • and fewer wound or abdominal wall infections

• at the cost of more urinary tract (bladder or ureter) injuries (OR 2.41) and longer operation time (MD 20.3 minutes).


• Results

– The benefits of LAVH versus TLH • were fewer febrile episodes or unspecified infection

• and shorter operation time (MD 25.3 minutes).


• Results

– There was no evidence of benefits of LH versus VH • and the operation time (MD 39.3 minutes)

• as well as substantial bleeding were increased in LH.

– Data were absent for many important long-term outcome

measures.


• Conclusions

– Because of equal or significantly better outcomes on all parameters, VH

should be performed in preference to AH where possible.

– Where VH is not possible, LH may avoid the need for AH however the length of the surgery increases as the extent of the surgery performed laparoscopically increases.

– The surgical approach to hysterectomy should be decided by the woman in discussion with her surgeon in light of the relative benefits and hazards.

FINHYST, a prospective study of 5279 hysterectomies: complications and their risk factors

Tea H.I. Brummer, Jyrki Jalkanen, Jaana Fraser, Anna Mari Heikkinen, Minna Kauko, Juha Mäkinen, Tomi Seppälä, Jari Sjöberg, Eija Tomás, and Päivi Härkki

Hum. Reprod. (2011) 26(7): 1741-1751


Hum. Reprod. (2011) 26(7): 1741-1751

• FINHYST is a national survey analysing complications of laparoscopic hysterectomy (LH), abdominal hysterectomy (AH) and vaginal hysterectomy (VH).

• FINHYST is a large prospective cohort study on hysterectomy for benign indications and involves unselected cases.

• Data were prospectively collected from 1 January to 31 December 2006.

• The number of hysterectomies reported was 5279, of which 44% were VH (n= 2345), 32% LH (n= 1679) and 24% AH (n= 1255).


Hum. Reprod. (2011) 26(7): 1741-1751

• Results

– Major complications rates in AH (n= 1255, 24%), LH (1679, 32%) and VH (2345, 44%) were 4.0, 4.3 and 2.6%, and total complications rates were 19.2, 15.4 and 11.7%, respectively.

– Logistic regression showed no statistically significant differences between approaches for any organ injuries or other major complications.

– Most bladder and bowel injuries (88 and 83%), but not ureter injuries (10%), were recognized intra-operatively.


Hum. Reprod. (2011) 26(7): 1741-1751

• Results

– The ureter injury rate was low after LH (0.3%), as it was after other types of hysterectomy.

– Compared with LH, AH increased the odds of wound infection, and was an independent risk factor for urinary infections and febrile events.

– Compared with AH, LH and VH both presented a higher risk for pelvic infection


Hum. Reprod. (2011) 26(7): 1741-1751

• Results

– No differences in complications emerged between LH and VH.

– Surgical adhesiolysis was the strongest single risk factor for major complications as a whole.


Hum. Reprod. (2011) 26(7): 1741-1751

• Results

– Bladder injury was associated with a history of caesarean section and with a large uterus ≥500 g.

– Bowel injury was associated with adhesiolysis.


Hum. Reprod. (2011) 26(7): 1741-1751

• Conclusions

– FINHYST is a large prospective hysterectomy study illustrating actual complications.

– The aim of FINHYST was to observe complications, and their determining factors, after hysterectomy for benign causes, in a prospective real-life national setting.

– However, a prospective multi-centre study is the best approach to obtain relative complication rates.

Laparoskopie vs Laparotomie

• Onkologie– Endometriumcarcinom– Ovarialcarcinom

• Onkologie robotic surgery

Laparoscopy versus laparotomy for the management of early stage endometrial cancer


Laparoscopy versus laparotomy for the management of early stage endometrial cancer Cochrane Database of Systematic Reviews Issue: Volume (9), 2012

• The aim of this review was to compare the overall survival and disease-free survival for laparoscopic surgery with laparotomy in women with presumed early endometrial cancer.

• Implications for practice

– For early stage endometrioid adenocarcinoma of the endometrium laparoscopy is associated with similar overall and disease-free survival.

Laparoscopy versus laparotomy for the management of early stage endometrial cancer Cochrane Database of Systematic Reviews Issue: Volume (9), 2012

• Implications for practice

– Laparoscopy is safe and is associated with reduced operative morbidity and hospital stay

– There is no significant difference in the quality of life between the two groups

Laparoscopy versus laparotomy for FIGO Stage I ovarian cancer


Laparoscopy versus laparotomy for FIGO Stage I ovarian cancer Cochrane Database of Systematic Reviews Issue: Volume (12), 2010

• Over the past ten years laparoscopy has become an increasingly common approach for the surgical removal of early stage ovarian tumours. There remains uncertainty about the value of this intervention.

• This review has been undertaken to assess the available evidence of the benefits and harms of laparoscopic surgery for the management of early stage ovarian cancer compared to laparotomy.


• The following issues were addressed in this review:

– Is laparoscopy (intervention group) effective in improving overall survival (OS) (compared with laparotomy (control group) in patients with FIGO stage I ovarian cancer?

– Is laparoscopy (intervention group) effective in improving progression free survival (PFS) compared with laparotomy (control group) in patients with FIGO stage I ovarian cancer?



– Does primary laparoscopy result in less surgical complications than laparotomy (control group) in patients with FIGO stage I ovarian cancer?

– Does primary laparoscopy (intervention group) result in more local recurrence (port site) than laparotomy (control group) in midline incision in patients with FIGO stage I ovarian cancer?



– Does primary laparoscopy (intervention group) result in more distant recurrence than laparotomy (control group) in patients with FIGO Stage I ovarian cancer?

– Does primary laparoscopy (intervention group) result more tumour spillage at the time of surgery than laparotomy (control group) in patients with FIGO stage I ovarian cancer?

– Does primary laparoscopy (intervention group) result in less cost than laparotomy (control group) in patients with FIGO stage I ovarian cancer?


• Results

– No RCTs were identified. Three observational studies were identified.

– This review has found no evidence to help quantify the value of laparoscopy for the management of early stage ovarian cancer as routine clinical practice.

– Survival data for patients with gynaecologic malignancies managed by laparoscopy are still lacking. It is imperative that the survival is not compromised by employing new surgical techniques.

Robotic assisted surgery for gynaecological cancer

Cochrane Gynaecological Cancer Group Cochrane Database of Systematic Reviews. 1, 2012.

Robotic assisted surgery for gynaecological cancer.Cochrane Gynaecological Cancer Group Cochrane Database of Systematic Reviews. 1, 2012.

• Robotic surgery is the latest innovation in the field of minimally invasive surgery. Robotic surgical systems have been used to perform surgery for endometrial, cervical cancer and ovarian cancer.

• No evidence from RCTs was identified to support using robotic

surgery for the treatment of gynaecological cancer at this time.

Robotic assisted surgery for gynaecological cancer.Cochrane Gynaecological Cancer Group Cochrane Database of Systematic Reviews. 1, 2012.

• Low quality evidence suggests that robotic surgery may have less intraoperative blood loss than with either laparoscopy or laparotomy and may decrease the conversion rate compared to laparoscopy.

• Additionally, robotic surgery may lead to fewer complications and shorter length of hospital stay than with laparotomy.

• Limited, poor quality data suggests that the survival of women with cervical cancer is similar in robotic surgery versus either laparoscopy or laparotomy, but this is likely to be heavily biased in non randomised case controlled studies.

Zusammenfassung

• Allgemeine Gynäkologie

• Onkologie

AUSBLICK

• Laparoskopie schonender als Lap

• Vag > LSK>Lap

• Onkologie gleiches Outcome

• Roboter?

Laparoskopie vs Laparotomie in der Gynäkologie Univ. Prof. Dr. Dr. h.c. Heinz Kölbl Klinische...

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