Reconstruction of the Pelvic Floor and Perineal Wound After Extralevatory Abdominal-perineal Extirpation of the Rectum
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 主要终点
- The assessment of the frequency of early postoperative complications
研究概览
简要总结
A multicenter, cohort, randomized, controlled study is being conducted since the 1of September, 2023 whereby the immediate and long-term results of pelvic floor and perineal wound plastic surgery after extralevatory abdominal-perineal extirpation of the rectum will be compared. The study is conducted on the basis of the Federal State Budgetary Educational Institution of the Ministry of Health Care of the Russian Federation, the Department of General Surgery at the clinical base of the State Budgetary Healthcare Institution " Krasnodar Regional Hospital No. 1 named after Professor S.V. Ochapovsky" of the Ministry of Health Care of the Krasnodar Territory, State Budgetary Healthcare Institution " Krasnodar Oncological Dispensary No. 1" of the Ministry of Health Care of the Krasnodar Territory The study included patients over 18 years old suffering from cancer of the lower ampullary rectum with T1-T4N0-2M0 (according to the classification of malignant tumors TNM in the 8th edition), who are scheduled for extralevatory abdominal-perineal extirpation of the rectum. Patients are randomized into 3 groups: the first group includes patients with plastic surgery in a simple way (Plastic surgery with local tissues), the second group includes patients with plastic surgery with a mesh endoprosthesis and the third one includes patients with plastic surgery in a new way.
The purpose of the study is to evaluate the effectiveness of the developed method of pelvic floor and perineal wound plastic surgery after extralevatory abdominal-perineal extirpation of the rectum. It is easily reproducible and provides high-quality closure of the deep and skin defect of the perineal wound. In addition, the new method will reduce the frequency of postoperative complications when compared with the use of conventional methods of closing the defect of the perineum, the method improves the quality of life and provides early rehabilitation of patients.
Study status- patients are being recruited. Number of patients selected is 150 patients. The primary endpoint of the study is the assessment of the early postoperative period and the frequency of postoperative complications (Flap necrosis; Suppuration; Hematoma; Bleeding; Seroma) within 30 days from the date of surgery. The study was approved by the Independent Ethics Committee Protocol No. 112 of 12th November, 2022.
It is planned to recruit patients within 2 years and monitor each of them for 30 days after surgery to assess the primary endpoint and to monitor patients within 1 year to assess the secondary endpoint. The secondary endpoint means an assessment of the frequency of late postoperative complications (perineal fistula, abscess, hernia) and an assessment of the quality of life within 1 year after surgery. It is planned to complete the study in 2025.
Eventually it is planned to publish the protocol of the study, the results obtained after the recruitment of the required number of patients as well as the results of evaluation of the primary endpoint.
详细描述
The aim of the study is to improve the results of pelvic floor and perineal wound plastic surgery after extralevatory abdominal-perineal extirpation (EAPE) of the rectum for cancer of the lower ampullary rectum by applying a new method of plastic surgery.
Being examined according to the standards of cancer treatment of the lower ampullary part of rectum, patients are hospitalized in the oncological surgery department. In the preoperative period, they are randomized by the Randomizer program into 3 groups by the head of the study on the day of surgery: the 1st Group includes patients to be made plastic surgery in a simple way (Plastic surgery with local tissues), the 2nd Group includes patients to be made plastic surgery with a mesh endoprosthesis and the 3rd Group includes patients to be made plastic surgery in a new way.
Patient data, clinical trial results, and randomization results are introduced into the Microsoft Access database.
The operation is carried out as follows: under combined endotracheal anesthesia after the completion of the abdominal and pelvic stage of the operation ending with the mobilization of the rectum which is carried out along the posterior wall to the level of V sacral vertebra corresponding to the bend of the sacrum; along the anterior wall that is the level of seminal vesicles, the upper pole of the prostate gland in men, the middle third of the vagina in women; along the lateral walls reaching the level of the pelvic nerve plexus and finally a single-stem colostomy is formed.
Suturing of the wound of the anterior abdominal wall with drainage of the pelvic cavity is performed. The patient is placed on his abdomen with his legs apart - "the position of a penknife". The operating surgeon is positioned between the patient's legs. Suturing of the skin of the perianal area with a pouch suture is performed after surgical treatment and limitation of the surgical area. Re-processing of the operating area is performed. It is made a fringing incision in the perianal region from the level of the sacrococcygeal joint, along the perianal-skin folds to the middle of the perineal seam. 2-4 sutures of wound fiber fixing to the skin of the external gluteal region may be applied for the purpose of additional traction in patients with severe obesity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years old suffering from cancer of the lower ampullary rectum cT1-T4N0-2M0 (according to the classification of malignant tumors TNM in the 8th edition).
- •Patients with planned extralevatory abdominal-perineal extirpation of the rectum.
- •Physical status of patients according to ASA classification I-II.
- •Signed informed consent to participate in the study.
- •Non-inclusion criteria:
- •Verification of the squamous cell carcinoma diagnosis.
- •The presence of acute purulent processes in the area of surgical intervention.
排除标准
- •Refusal to participate at any stage of the study.
- •Death in the early postoperative period (up to 30 days after surgery) caused by somatic complications not associated with surgery (PATE, myocardial infarction, stroke).
结局指标
主要结局
The assessment of the frequency of early postoperative complications
时间窗: Within 30 days from the date of surgery
Early postoperative complications to be assessed: flap necrosis; suppuration; hematoma; bleeding; seroma
次要结局
- The assessment of the frequency of late postoperative complications and quality of life(Within 1 year after surgery)
研究者
Vadim Polovinkin
Doctor of Medical Sciences, Head of the Department of General Surgery of Kuban State Medical University
Kuban State Medical University