Dataset Information

Effect of single-incision plus one port laparoscopic surgery assisted with enhanced recovery after surgery on colorectal cancer: study protocol for a single-arm trial

ABSTRACT:

Background

Studies have proved that the enhanced recovery after surgery (ERAS) protocol can significantly improve the recovery course of patients during the perioperative period. The application of minimally invasive surgery is a critical component of ERAS protocol. Single-incision plus one port laparoscopic surgery (SILS plus one) could achieve further minimally invasive surgical results than conventional laparoscopic surgery (CLS). The objective of this trial is to evaluate the safety and feasibility of SILS plus one with ERAS protocol in colorectal cancer.

Methods

This is a prospective, single-center, open-label, single-arm trial. A total of 120 eligible patients with colorectal cancer will receive SILS plus one followed by the ERAS management during the perioperative period. The primary endpoint is postoperative hospital stay. The secondary endpoints include rehabilitative rate of the fourth postoperative day, postoperative medical cost, postoperative pain score, postoperative recovery indexes, inflammatory immune response indexes, compliance with ERAS measures, 6 min postoperative walking test (6MWT), hospital readmissions, and early postoperative complications.

Discussion

This trial will be the first to evaluate the short-term outcomes of SILS plus one assisted with ERAS protocol for patients with colorectal cancer and will provide valuable clinical evidence on the benefit of the combination of these two techniques, hopefully, to provide patients with more safe, economic, feasible, and rapid surgery and perioperative strategies.

Trial Registration

Clinical Trial Registry, NCT0426829. Registered February 15, 2020 (https://clinicaltrials.gov/ct2/show/NCT04268290).

SUBMITTER: Zhang X

PROVIDER: S-EPMC8799928 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Background: Laparoscopy is rapidly replacing laparotomy in the field of gynecologic surgery. Generally, there are limited data concerning the utility of single-incision laparoscopic surgery (SILS) in gynecologic surgery. Specifically, in Saudi Arabia, a third-world country, data are further limited; only one related study has been conducted so far. The purpose of this study is to retrospectively report our single-institutional experience of SILS in terms of feasibility, safety and perioperative outcomes in the management of various gynecologic conditions. Methods: The study took place at the Women's Specialized Hospital, King Fahad Medical City, Riyadh, Saudi Arabia. From January 2012 to May 2016, all gynecologic patients who underwent SILS procedures were analyzed for pre-, intra- and post-operative details. SILS was performed using a single multi-port trocar and standard laparoscopic instruments. Results: A total of 54 patients underwent 66 SILS procedures. The median age and body mass index (BMI) were 36 years and 28.2 kg/m 2, respectively. Fourteen patients (26%) had ? 1 previous abdominal and/or pelvic surgeries. Twenty-four patients (44.4%) were nulliparous. The three most commonly performed SILS procedures were unilateral salpingo-oophorectomy (45.5%) and unilateral ovarian cystectomy (27.3%) and adhesiolysis (6.1%). The median operative time, estimated blood loss and hospital stay were 74 min, 50 ml and 1 day, respectively. Three patients required conversion to laparotomy, as follows: unidentified non-stopping bleeding source (n=1) and endometriosis stage IV resulting in difficult dissection (n=2). One patient developed post-operative incisional hernia that was treated surgically. The median patients' post-operative pain (according to Wong-Baker FACES Foundation pain rating scale) within 4 hours was 2. At 4-week post-operatively, the median wound scar length (measured at outpatient clinic) was 2 cm. Conclusions: SILS is feasible, safe and associated with acceptable clinical and surgical outcomes.