Impact of Peritoneal Gas Drain on Postoperative Pain for Gynaecological Cancer Patients With Minimally Invasive Surgery

NCT ID: NCT04974125

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-07
• Study Completion Date: 2023-12-11

Brief Summary

This is a phase III, monocenter and randomized study, which evaluates the effectiveness of peritoneal gas drainage on postoperative pain in laparoscopic or robotic laparoscopic gynaecological surgery. This study aim is to assess the efficacy of active gas extraction with a drain (arm A) in comparison to manual evacuation (arm B,) in terms of pain incidence reduction linked to laparoscopic or robotic laparoscopic surgery.

Detailed Description

The primary objective is to assess the efficacy of active gas aspiration compared to simple manual gas evacuation to reduce the incidence of specific laparoscopic surgery pain.

Secondary objectives of this study include :

• Comparing the evolution of specific pains after laparoscopic surgery, between study groups
• Description of postoperative antalgics consumption in each group
• Evaluating the safety of the evaluated procedure
• Evaluating the impact of the evaluated procedure on hospitalisation duration ( for patients with ambulatory surgery initially planned)

Conditions

Gynaecologic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Arm A :Aspiration of peritoneal gas through a drain

Patients in experimental arm will receive surgery (either laparoscopic or robotised laparoscopic surgery). The exsufflation will be carrying out by a drain.

Then, patients will be followed-up during 7 days after surgery.

Group Type: EXPERIMENTAL

Drain

Intervention Type: PROCEDURE

A 10 mm suction drain is placed through a trocar in the right hypochondrium (liver).

Arm B : Manual evacuation of the peritoneal gas, via the trocar

Laparoscopic or robotised laparoscopic surgery + Trocar

Patient in this experimental arm will receive surgery (either laparoscopic or robotised laparoscopic surgery). The exsufflation will be carrying out carried out manually using the trocar (standard of care).Then, patient will be followed-up during 7 days after surgery.

Group Type: ACTIVE_COMPARATOR

Manual exsufflation

Intervention Type: PROCEDURE

Exsufflation through the trocar opening.

Interventions

Drain

A 10 mm suction drain is placed through a trocar in the right hypochondrium (liver).

Intervention Type: PROCEDURE

Manual exsufflation

Exsufflation through the trocar opening.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 ans ;
• Woman who underwent laparoscopic or robotised laparoscopic surgery in peritoneal cavity (benign or malignant gynaecological affection) ;
• Planned ambulatory surgery
• Patient willing and able to be treated and followed according the protocol during the trial ;
• Patient covered by the French "Social Security" regime ;
• Effective contraception for reproductive age patients ;
• Signed written informed consent before surgery

Per-operatory eligibility criterion :

• No conversion from laparoscopic surgery to laparotomy surgery

Exclusion Criteria

• Extra-peritoneal surgery scheduled ( example : aortic dissection) ;
• Upper-abdomen surgery (example : liver, gall bladder) ;
• History of shoulders pains prior to surgery (the assessment must be carried out within a period of 30 days before the surgery) ;
• Inability to comply with medical follow-up of the trial (geographical, social or psychic reasons)
• Person under guardianship
• Pregnant or breastfeeding woman

Non eligibility criterion known during the operation :

• Conversion from laparoscopic surgery to laparotomy surgery

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Oscar Lambret

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fabrice NARDUCCI, PhD

Role: STUDY_DIRECTOR

Centre Oscar Lambret

Locations

Fabrice NARDUCCI

Lille, , France

Countries

France

Other Identifiers

DRAIN-EXSU-1907

Identifier Type: -

Identifier Source: org_study_id