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OpenTrials
Completed

NCT Number: NCT06391060

Gender Differences in Robotic Surgery for Rectal Cancer: a Retrospective Study

Objective: To investigate gender-based differences in outcomes following robotic surgery for rectal cancer.

Methods: A retrospective study was conducted on 155 patients (82 males, 73 females) who underwent robotic surgery for rectal cancer. Demographic, pre-operative, operative, and post-operative data were collected and analyzed.

Pre-operative study:

All patients underwent a standardized pre-operative work-up, which included a physical examination, comprehensive colonoscopy with biopsy, rigid rectoscopy, pelvic magnetic resonance imaging (MRI) scan, computed tomography (CT) of the thorax and abdomen, and measurement of carcinoembryonic antigen (CEA) levels. Tumor staging followed the TNM staging criteria (American Joint Committee on Cancer), with the T and N stages determined by the most advanced findings from any imaging modality

Data collected:

Retrospective evaluation and comparison of demographic characteristics, pre-operative TNM stage, distance from anal verge, tumor size, tumor grade, American Society of Anesthesiologists (ASA) score, and body mass index (BMI) were conducted among both patient groups. Peri-operative and post-operative data, including morbidity and mortality, were assessed, alongside parameters such as distal resection margin (DRM), proximal resection margin (PRM), harvested lymph nodes (HLN), and Clavien-Dindo Classification (CDC) scores. Diagnosis of anastomotic leakage was confirmed by clinical suspicion (e.g., changes in drainage, fever, abdominal pain) and further validated through contrast enema observed during follow-up computed tomography (CT). Hospital stay and readmission rates were monitored for up to 90 days post-surgery.

Post-operative follow-up:

Post-operative outcomes encompassed operative duration, estimated blood loss, time to first flatus passage, duration of liquid diet, and length of hospital stay following surgery. Operative duration comprised the time from initial skin incision to closure, including the time needed for robotic surgery docking and undocking. Upon experiencing initial flatulence, patients transitioned to a liquid diet. Hospital stay duration was measured from the time of surgery to discharge. The overall cost of surgery, including surgical procedures, anesthesia, medications, and post-operative care, was considered in the total expenditure analysis.

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Key information

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

A confirmed histological diagnosis of colorectal malignancy was a prerequisite for enrollment in this study. Additionally, obtaining informed consent from patients for surgical intervention was mandatory.

Exclusion criteria

Patients with bleeding of the gastrointestinal tract, inflammatory bowel disease, synchronous tumors, benign conditions, and clinical T4 stage tumors unresponsive to neoadjuvant therapy were excluded from the study.

Treatment and study plan

Impact of Gender on Davinci rectal surgery

Procedure

gender-specific considerations in the surgical management and post-operative care of rectal cancer patients undergoing robotic surgery

Other names: Davinci

Primary outcomes

  1. Gender Differences in Robotic Surgery for Rectal Cancer: a retrospective study

    Time frame: 15th of April 2024

    gender-specific considerations in the surgical management and post-operative care of rectal cancer patients undergoing robotic surgery

Sponsors and collaborators

Lead sponsor

Daorong Wang

Other

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Apr 30, 2024
Registry last updated
Apr 30, 2024

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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