[Clinical study of using basement membrane biological products in pelvic floor reconstruction during pelvic exenteration].

Objective: To investigate the value of reconstruction of pelvic floor with biological products to prevent and treat empty pelvic syndrome after pelvic exenteration (PE) for locally advanced or recurrent rectal cancer. Methods: This was a descriptive study of data of 56 patients with locally advanced or locally recurrent rectal cancer without or with limited extra-pelvic metastases who had undergone PE and pelvic floor reconstruction using basement membrane biologic products to separate the abdominal and pelvic cavities in the Department of Anorectal Surgery of the Second Affiliated Hospital of Naval Military Medical University from November 2021 to May 2022. The extent of surgery was divided into two categories: mainly inside the pelvis (41 patients) and including pelvic wall resection (15 patients). In all procedures, basement membrane biologic products were used to reconstruct the pelvic floor and separate the abdominal and pelvic cavities. The procedures included a transperitoneal approach, in which biologic products were used to cover the retroperitoneal defect and the pelvic entrance from the Treitz ligament to the sacral promontory and sutured to the lateral peritoneum, the peritoneal margin of the retained organs in the anterior pelvis, or the pubic arch and pubic symphysis; and a sacrococcygeal approach in which biologic products were used to reconstruct the defect in the pelvic muscle-sacral plane. Variables assessed included patients' baseline information (including sex, age, history of preoperative radiotherapy, recurrence or primary, and extra-pelvic metastases), surgery-related variables (including extent of organ resection, operative time, intraoperative bleeding, and tissue restoration), post-operative recovery (time to recovery of bowel function and time to recovery from empty pelvic syndrome), complications, and findings on follow-up. Postoperative complications were graded using the Clavien-Dindo classification. Results: The median age of the 41 patients whose surgery was mainly inside the pelvis was 57 (31-82) years. The patients comprised 25 men and 16 women. Of these 41 patients, 23 had locally advanced disease and 18 had locally recurrent disease; 32 had a history of chemotherapy/immunotherapy/targeted therapy and 24 of radiation therapy. Among these patients, the median operative time, median intraoperative bleeding, median time to recovery of bowel function, and median time to resolution of empty pelvic syndrome were 440 (240-1020) minutes, 650 (200-4000) ml, 3 (1-9) days, and 14 (5-105) days, respectively. As for postoperative complications, 37 patients had Clavien-Dindo < grade III and four had ≥ grade III complications. One patient died of multiple organ failure 7 days after surgery, two underwent second surgeries because of massive bleeding from their pelvic floor wounds, and one was successfully resuscitated from respiratory failure. In contrast, the median age of the 15 patients whose procedure included combined pelvic and pelvic wall resection was 61 (43-76) years, they comprised eight men and seven women, four had locally advanced disease and 11 had locally recurrent disease. All had a history of chemotherapy/ immunotherapy and 13 had a history of radiation therapy. The median operative time, median intraoperative bleeding, median time to recovery of bowel function, and median time to relief of empty pelvic syndrome were 600 (360-960) minutes, 1600 (400-4000) ml, 3 (2-7) days, and 68 (7-120) days, respectively, in this subgroup of patients. Twelve of these patients had Clavien-Dindo < grade III and three had ≥ grade III postoperative complications. Follow-up was until 31 October 2022 or death; the median follow-up time was 9 (5-12) months. One patient in this group died 3 months after surgery because of rapid tumor progression. The remaining 54 patients have survived to date and no local recurrences have been detected at the surgical site. Conclusion: The use of basement membrane biologic products for pelvic floor reconstruction and separation of the abdominal and pelvic cavities during PE for locally advanced or recurrent rectal cancer is safe, effective, and feasible. It improves the perioperative safety of PE and warrants more implementation.目的： 探究生物补片重建盆底在局部晚期或局部复发直肠癌盆腔脏器联合切除手术中的临床应用。 方法： 本研究为描述性病例系列研究，回顾性收集海军军医大学第二附属医院肛肠外科于2021年11月至2022年5月期间，收治的局部晚期或局部复发直肠癌无盆腔外转移、或仅有寡转移而接受盆腔脏器联合切除术，同时使用基底膜生物补片重建盆底隔离腹盆腔的56例患者围手术期资料，手术范围分为主要局限在骨盆腔内（骨盆腔内切除组，41例）及合并骨盆壁主要组织切除（合并骨盆壁主要组织切除组，15例）两类。所有手术应用基底膜生物补片重建盆底、隔离腹盆腔，具体包括经腹补片覆盖Treitz韧带至骶骨岬的后腹膜缺损和骨盆入口，补片四周分别与侧腹膜和前盆留存脏器的腹膜缘缝合、或固定于耻骨弓及耻骨联合；或经骶尾入路，补片重建盆底肌-骶骨平面缺损。观察指标包括患者基线资料（性别、年龄、术前放化疗史、复发或原发、盆腔外转移等）和手术情况（脏器切除范围、手术时间、术中出血量、组织重建等）；围手术期空盆脏综合征发生情况以及痊愈时间；术后恢复（肠功能恢复时间、空盆腔综合征痊愈时间）和并发症情况以及随访情况。术后并发症采用国际Clavien-Dindo分级进行评价。 结果： 骨盆腔内切除组41例患者中位年龄57（31~82）岁，男25例、女16例；其中23例为局部晚期直肠癌，18例为局部复发直肠癌；32例有化疗、免疫和靶向治疗史，24例有放疗史；中位手术时间440（240~1 020）min；术中中位出血量650（200~4 000）ml；肠功能恢复中位时间3（1~9）d；空盆腔综合征中位痊愈时间14（5~105）d；术后并发症<Ⅲ级者37例，≥Ⅲ级并发症的4例患者中，1例术后7 d因多器官功能衰竭死亡，2例术后盆底创面大出血予以二次手术止血，1例术后呼吸衰竭经抢救后痊愈。合并骨盆壁主要组织切除组15例患者中位年龄61（43~76）岁，男8例、女7例；4例为局部晚期直肠癌，11例为局部复发直肠癌，均有化疗、免疫和靶向治疗史，13例有放疗史；中位手术时间600（360~960）min；术中中位出血量1 600（400~4 000）ml；肠功能恢复中位时间3（2~7）d；空盆腔综合征中位恢复时间68（7~120）d；术后并发症<Ⅲ级者12例，≥Ⅲ级的3例患者中，2例术后盆底创面大出血予以二次手术止血，1例术后肠梗阻二次手术后痊愈。随访截至2022年10月31日或病例死亡，55例患者中位随访时间为9（5~12）个月，随访期内合并骨盆壁主要组织切除组1例患者因肿瘤快速进展术后3个月死亡。其余54例均存活，未见手术部位肿瘤复发。 结论： 基底膜生物补片应用于局部晚期或局部复发直肠癌行盆腔脏器联合切除手术重建盆底、隔离腹盆腔，安全可行，可能会提高盆腔脏器联合切除手术围手术期的安全性。.