An interventional study of Laparoscopic right hemicolectomy with transrectal specimen extraction in Colon Cancer, sponsored by National Cancer Center, China. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-04-12.
Sponsored by National Cancer Center, China · Not applicable, Interventional, and Treatment
The purpose of this study is to investigate the preliminary surgical outcomes of laparoscopic right hemicolectomy with transrectal specimen extraction. The hypothesis is that this type of natural orifice specimen extraction surgery (NOSES) could achieve good short-term and oncological outcomes for right colon cancer patients.
This study is a prospective single-arm clinical study. 37 patients with right colon cancer undergoing laparoscopic right hemicolectomy with transrectal specimen extraction are planned to be included in the study. The purpose of this study is to investigate the preliminary surgical outcomes of laparoscopic right hemicolectomy with transrectal specimen extraction. The primary endpoint is the postoperative complications of this type of natural orifice specimen extraction surgery (NOSES). The primary hypothesis is that NOSES could reduce postoperative complications. In addition, operating time, intraoperative bleeding, post-operative recovery and quality of life (QoL) are secondary endpoints.
1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.
This study's planned enrollment of 37 is below the median of 90 across 1,034 interventional studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →National Cancer Center, China is the lead sponsor of 10 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
STEP 1: Dissection and separation The mesentery and vessels were dissected and separated according to the principle of complete mesocolic excision. STEP 2: Intracorporeal anastomosis An enterotomy was performed on the antimesenteric side of the ileum at the edge of the staple line. This maneuver was replicated on the transverse colic side. Subsequently, the cartridge jaw of the stapler was inserted into the transverse colon. The stapler was fired and withdrawn, and the common enterotomy was sealed by using another linear stapler. STEP 3: Transrectal specimen extraction A longitudinal incision was made on the anterior of wall of the upper rectum. The assistant employed oval forceps to extract the specimen along with the protective sleeve through the incision in the upper rectum. After the complete extraction of the specimen, a full-layer running suturing was performed to close the incision.
Procedure: Laparoscopic right hemicolectomy with transrectal specimen extraction
Laparoscopic right hemicolectomy with transrectal specimen extraction
The rate of postoperative complications
The rate of postoperative complications = patients with any postoperative complications/all cases.
Time frame: up to 30 days
Operating time
Operating time = The Operative time was defined as the time first skin incision was made to final skin closure
Time frame: up to 1 days
Estimated blood loss
Estimated blood loss = The sum of the blood in the suction canister (the total volume after subtracting the amount of irrigation fluid used) and the segment of increased weight of swabs used during operation phase (1 ml of blood is about weighs 1g)
Time frame: up to 1 days
The time of first flatus
The time of first flatus = The time of first flatus reported by patients
Time frame: up to 5 days
Postoperative hospitalization
Postoperative hospitalization = the number of nights from surgery to discharge
Time frame: up to 30 days
Plan to share: No — Participants' data are only allowed to be used for the analysis of this study and are not authorized to be shared with other researchers.
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National Cancer Center, China