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Completed

NCT Number: NCT04974125

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fabrice NARDUCCI

Lille, 59020, France

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Drain

Procedure

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

Manual exsufflation

Procedure

Exsufflation through the trocar opening.

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)

    Time frame: During the 24 hours after surgery

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

Secondary outcomes

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

    Time frame: 24 hours after surgery

    The maximum score pain will be evaluated by the mean difference between each group (Student or Mann-Whitney tests).

  2. Assess pain at trocar holes comparatively in the two groups

    Time frame: 24 hours after surgery

    The site of pain will be reported to describe pain overall, but also specifically in the shoulders and/or subcostal areas and pain at trocar holes.

    Pain will be measured with the numerical pain assessment scale (score from 0 to 10).

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

    Time frame: 7 days after surgery

    A notebook filled in by the patient at home with a daily assessment of pain according to the numerical pain assessment scale, with a phone call from the nurse on day 7 (considering that the day of the surgery is day 0).

  4. Antalgics consumption

    Time frame: 24 hours and 7 days after surgery

    Qualitative description through patient notebook.

  5. Antalgics consumption

    Time frame: 24 hours and 7 days after surgery

    Quantitative description through patient notebook.

  6. Adverse events (AE) (grade ≥III Clavien-Dindo classification)

    Time frame: 30 days after surgery

    Safety procedure will be describe through adverse events notification potentially related to the procedure and their grade (total amount of AE, maximal grade of AE per patient).

  7. Evaluate the impact of the evaluated procedure on the hospitalisation duration

    Time frame: Through the study patient participation, an average of 2 months

    Impact of the peritoneal gas aspiration technique on the hospitalisation duration for patient with ambulatory surgery.

Sponsors and collaborators

Lead sponsor

Centre Oscar Lambret

Other

Registry information

Official study title

Drain-Exsu: Phase III Trial Assessing the Effect of Peritoneal Gas Drain on Postoperative Pain in Gynecologic Minimally Invasive Surgery

Acronym: DRAIN-EXSU

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 23, 2021
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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