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

NCT04974125 | Completed

• 2 other identifiers: DRAIN-EXSU-19072021-A00602-39
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynaecologic Cancer

Keywords

Postoperative pain; Peritoneal gas drainage; Laparoscopic gynaecological surgery; Robotised laparoscopic gynaecological surgery

Outcome Measures

Primary Outcomes (1)

• Specific pain (shoulders and/or subcostal areas) related to the laparoscopic surgery (Day 0), measured with a numerical pain assessment scale (score from 0 to 10)

  Comparison on portion of patients with significative early pain linked to the laparoscopic surgery, between the two groups (Chi-2 tests).

  During the 24 hours after surgery

Secondary Outcomes (7)

• Maximal score pain, measured with a numerical pain assessment scale (score from 0 to 10)

  24 hours after surgery

• Assess pain at trocar holes comparatively in the two groups

  24 hours after surgery

• Laparoscopic surgery specific pains, measured with a numerical pain assessment scale (score from 0 to 10)

  7 days after surgery

• Antalgics consumption

  24 hours and 7 days after surgery

• Antalgics consumption

  24 hours and 7 days after surgery

Study Arms (2)

Arm A :Aspiration of peritoneal gas through a drain

EXPERIMENTAL

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.

Procedure: Drain

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

ACTIVE COMPARATOR

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.

Procedure: Manual exsufflation

Interventions

Drain PROCEDURE

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

Arm A :Aspiration of peritoneal gas through a drain

Manual exsufflation PROCEDURE

Exsufflation through the trocar opening.

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

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Gynaecological cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Oscar Lambret: lead

Study Sites (1)

Fabrice NARDUCCI

Lille, 59020, France

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Drainage

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Surgical Procedures, Operative

Study Officials

• Fabrice NARDUCCI, PhD

  Centre Oscar Lambret

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patient will be pre-selected before medical operation. During the surgery, if the surgeon performs only the laparoscopy, the patient will be randomized. Then, the allocated procedure (with or without drain) will be carried out.

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: July 23, 2021
• Study Start: January 7, 2022
• Primary Completion: December 11, 2023
• Study Completion: December 11, 2023
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

FR (1)