Clinical trial · Interventional
Impact of Peritoneal Gas Drain on Postoperative Pain for Gynaecological Cancer Patients With Minimally Invasive Surgery
Drain-Exsu: Phase III Trial Assessing the Effect of Peritoneal Gas Drain on Postoperative Pain in Gynecologic Minimally Invasive Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gynaecologic Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Drain | Procedure | — | UNRESOLVED |
| Manual exsufflation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A :Aspiration of peritoneal gas through a drain
- description
- 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.
- interventionNames
- Procedure: Drain
- type
- ACTIVE_COMPARATOR
- label
- Arm B : Manual evacuation of the peritoneal gas, via the trocar
- description
- 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.
- interventionNames
- Procedure: Manual exsufflation
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available