An interventional study of Conventional pressure laparoscopy and Low pressure laparoscopy in Colonic Disease, sponsored by Institut Paoli-Calmettes. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-09.
Sponsored by Institut Paoli-Calmettes · Not applicable, Interventional, and Treatment
The laparoscopic surgery requires gas insufflation in the peritoneal cavity and the operator chooses the intraabdominal insufflation pressure. In general, during a conventional laparoscopy, this pressure is 12 to 15 mmHg. The reduction of the intra-abdominal pressure minimizes the parietal trauma due to the insufflation and could lead to a reduction of the postoperative pains and could allow an earlier recovery. In this study, the investigator propose to evaluate the benefits of a low pressure insufflation (6-8 mmHg) with pressure-controlled insufflator in patients with a mild or malignant colon pathology requiring surgical colic resection. The main objective of the study is to demonstrate that the laparoscopic colic resection at low pressure reduces the theoretical hospital stay of one day compared to the conventional laparoscopy.
147 studies on the registry are indexed under Colonic Diseases; 23 are open to participants now.
This study's enrollment of 128 is below the median of 143 across 95 interventional studies indexed under Colonic Diseases.
Browse Colonic Diseases studies →Institut Paoli-Calmettes is the lead sponsor of 172 studies on the registry; 50 are open to participants now.
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Exclusion Criteria:
Laparoscopy realized at the conventional pressure (12-15 mmHg) using conventional insufflator.
Procedure: Conventional pressure laparoscopy
Laparoscopy realized at low pressure (6-8mmHg) using pressure-controlled insufflator AirSeal®
Procedure: Low pressure laparoscopy
Conventional pressure laparoscopy using conventional insufflator AirSeal®
Low pressure laparoscopy using pressure-controlled insufflator AirSeal®
The theoretical hospital stay
The theoretical hospital stay in days (calculated from the day of the surgery to the theoretical day of discharge according to predefined exit criteria)
Time frame: from hospitalization day until hospital discharge, assessed up to 15 days
Morbidity rate
Morbidity evaluated according Dindo-clavien classification
Time frame: 20 days post surgery
Mortality rate
Dead patient listing
Time frame: 20 days post surgery
GastroIntestinal-Quality-of-Life Index (GIQLI)
GastroIntestinal-Quality-of-Life Index (GIQLI) questionnaire, 36 questions, each containing 4 answers equating to a score ranging from 0 (least desirable answer) to 4 (most desirable answer). Total score range 0-144.
Time frame: 20 days and 3 months post surgery
Short Form Health (SF12) score
This questionnaire is an abbreviated version of the "Medical Outcomes Study Short-Form General Health Survey" (SF-36) contains only 12 items out of 36 with minimum score 0 (bad quality life) and maximum score at 100 (good quality life).
Time frame: 20 days and 3 months post surgery
Pain score using self-report pain assessment tool (EVA)
EVA measures the intensity of pain on a scale of 0 (no pain) to 10 (maximum pain imaginable)
Time frame: From surgery to hospital discharge assessed up to 15 days, at 20 days and at 3 months post surgery
Intestinal transit recovery time frame
Period duration from surgery to intestinal gas recovery time (in days)
Time frame: From surgery to transit recovery assessed up to 15 days
Nausea and vomiting incidence
Nausea and vomiting listing
Time frame: From surgery to hospital discharge assessed up to 15 days
Analgesic treatment incidence
Non-morphine and morphine analgesic consumption
Time frame: From surgery to 3 months post surgery
Real hospitalization duration
Real hospitalization duration (actual patient discharge date based on non-medical criteria)
Time frame: From hospitalization day until hospital discharge assessed up to 15 days
Rehospitalization number
Rehospitalization listing
Time frame: from hospital discharge assessed up to 15 days to 3 months post surgery
Differential cost of patient care
According operating room occupation and real hospital stay
Time frame: From surgery to hospital discharge assessed up to 15 days
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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