An Open-label, Randomized, Prospective Study of the Effectiveness, Safety, and Clinical Outcomes … (NCT00888849) | Clinical Trial Compass
CompletedNot Applicable
An Open-label, Randomized, Prospective Study of the Effectiveness, Safety, and Clinical Outcomes of Stapled Anastomoses Versus Hand-Sutured Anastomoses in Patients Undergoing Gastrointestinal End to End or Side to Side Anastomoses
India280 participantsStarted 2009-04
Plain-language summary
This study is being conducted to compare surgical and patient outcomes across stapled (Group II) versus hand-sutured (Group I) groups.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:a.
* Able to comprehend and sign or, if illiterate, leave their thumb impression on the study informed consent document
* 18 years to 75 years (inclusive)
* Admitted on an emergency or elective basis requiring a single gastrointestinal anastomosis
* Willing to adhere to standard postoperative care, including ventilator support if required
* Female subject is postmenopausal (for at least 2 years) or surgically incapable of child bearing (at least 3 months post-surgical sterilization, with appropriate documentation)
* If female subject is capable of child bearing, must use an acceptable method of birth control (hormonal or IUD) for at least 3 months prior to surgery and continue use throughout the study; maintained normal menstrual pattern for the past three months and has a negative urine pregnancy test prior to day of surgical procedure
* Absence of medical history of psychiatric disorders that could limit the subject's ability to understand the procedure, comply with medical, surgical, and/or behavioral recommendations.
Exclusion Criteria:
* Women of childbearing potential who are pregnant at the time of screening or at the time of surgery
* Subject is on treatment with Corticosteroid maintenance therapy (equivalent to \> 10mg/day of Prednisone), immunosuppressive or chemotherapeutic agents within 14 days prior to enrollment; or likely to receive one of these drugs during study period
* Subject has connective tissue disease, renal failure necessitating …
What they're measuring
1
Time of Surgery (Skin Open to Skin Close)
Timeframe: Day 1
2
Time of Anastomosis
Timeframe: Total time (minutes) from placement of stay suture to final anastomotic staple (Group II) or final anastomotic suture (Group I)
3
Return to Bowel Activity
Timeframe: Number of days post-surgery to appearance of peristaltic movement