Endoscopic Reconstruction of the Gastrointestinal Tract After Surgical Resection Procedures Within the Large Intestine (Hartmann's Procedure- Modification of the Method Facilitating the Restoration of Gastrointestinal Continuity)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Rate of efficacy of endoscopic gastrointestinal anastomoses using transmural self-expandable prostheses to restore the gastrointestinal continuity in patients after Hartmann procedure (Endo-HARP)
研究概览
简要总结
The goal of this clinical trial is to learn about clinical usefulness endoscopic gastrointestinal anastomoses to restore the gastrointestinal continuity in patients with permanent colostomy after Hartmann procedure.
The main questions it aims to answer are:
- is the endoscopic restore the gastrointestinal continuity procedure effective?
- is this endoscopic procedure safe?
详细描述
Large intestinal resection is performed for both elective and acute reasons. The choice of surgical technique is determined not only by the oncological treatment outcome, but also by the patient's quality of life after surgery. Intestinal anastomosis is associated with the risk of leakage, which is one of the most serious complications of colorectal surgery. In the event of this complication, the most common treatments are relaparotomy/relaparoscopy and disconnection of the anastomosis with stoma formation. The patient's condition is most often critical, and the mortality associated with this complication ranges from 1.3 to 27% depending on the patient's age. In addition, dehiscence of the intestinal anastomosis during oncological surgery is an independent factor that increases the risk of local recurrence and shortens disease-related survival. In contrast, avoiding primary anastomosis and performing Hartmann's surgery (resection with the formation of an end colostomy) is safer for the patient as there is no risk of anastomotic leak. However, this procedure is not ideal. The patient undergoes an end colostomy, which is often difficult for the patient to accept, especially during the initial period. Restoration of gastrointestinal continuity is possible a few months after primary surgery. In colorectal cancer, it can be treated only after the completion of adjuvant chemotherapy, which significantly prolongs this process. Stoma closure has never been attempted in many patients because of the risks associated with another major surgery. Therefore, it is not surprising that there is a trend towards performing primary anastomosis. In experienced centers, the risk of anastomotic dehiscence is at an acceptable level of less than 5% for elective surgeries. In contrast, the percentage is higher for acute surgeries, accounting for up to 20% of emergency indications, especially in centers inexperienced in colorectal surgery. Gastrointestinal obstruction, which is most often associated with colorectal tumors, leads to dilatation of the proximal segment of the large intestine (above the tumor) with wall thickening. Disproportion in diameter, edema, thickening of the intestinal wall, and serious conditions with accompanying malnutrition significantly increased the risk of anastomotic leak in this group of patients. Currently, due to advances in pharmacological treatment and interventional radiology (percutaneous abscess drainage), surgical treatment involving segmental intestinal resection is reserved for patients with diffuse peritonitis. In this group of patients, resection with a primary anastomosis is associated with a very high risk of anastomotic failure, and Hartmann's resection remains the safest option.
Previous methods for restoring gastrointestinal continuity after Hartmann's procedure required extensive surgery. The first stage of surgery involves the dissection of adhesions after the previous resection. It is usually the most technically difficult stage of the procedure because of the emergency nature of the primary surgery (obstruction/peritonitis). Once the intestinal adhesions are removed, the colostomy is dissected from the wall, and the descending and sigmoid colons are mobilized. This is most often associated with the need to release splenic flexure. The next step is to identify and mobilize the rectal stump. This is necessary for a safe intestinal anastomosis, which is most often performed using a circular stapler. If a long rectal stump remains after the primary surgery, insertion of the stapler into its terminal segment is sometimes difficult and involves dissection and cutting of the pelvic peritoneum. Restoring gastrointestinal continuity after Hartmann's surgery is technically difficult and carries a high risk of intra- and perioperative complications, with the most common being small/large intestinal injury during adhesion dissection, intraoperative bleeding, ureteral/bladder injury, and splenic injury (most often, the splenic flexure needs to be released). No technical possibility of reconstruction is common (displacement of the rectal stump deep inside the pelvis and shortening of the mesentery of the left half of the colon). The risk of complications related to the restoration of gastrointestinal continuity after Hartmann's surgery is 30-60%; thus, a significant number of patients do not consent to this procedure.
The endoHARP procedure proposed in this article allows easier restoration of gastrointestinal continuity owing to the combination of classic colorectal surgical techniques with endosonography techniques. The technical details of the procedure are described later in this article. To ensure the feasibility of the endoHARP procedure, it is necessary to slightly modify the primary resection procedure using Hartmann's method. After the resection stage, which does not differ from the original surgery, the remaining parts of the sigmoid and descending colon should be mobilized at the promontorium level. This allows fixation of the closed rectal stump. Side-to-end anastomosis of the intestine to the rectal stump was performed using four 3-0 absorbable sutures. The end of the sigmoid colon is typically brought out into the left middle abdomen. However, this procedure may not be feasible for all patients. It is not possible to use this modification in most cases involving a short segment of the remaining left half of the colon, those with inflammatory infiltration within the mesentery, or those requiring anterior rectal resection (low-sigmoid tumors). However, this modification is technically feasible in a considerable number of patients undergoing Hartmann's procedure.
The steps of the modified Hartmann's sigmoid resection procedure are summarized below.
- Resection of the sigmoid colon performed as in the original method
- Mobilization of the remaining part of the sigmoid and descending colon
- Possible mobilization of the splenic flexure
- Fixation of the descending and sigmoid colon to the rectal stump with four 3-0 serous sutures
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •participants of both sexes aged above 18 years
- •participants, who provided informed consent for such treatment
- •eligibility for Hartmann's procedure according to current medical knowledge based on evidence-based medicine.
排除标准
- •pregnancy, breastfeeding, or intention to become pregnant during the study
- •contraindications to electrosurgical instruments
- •allergy to any of the materials used in the study
- •participants with advanced cancer in the metastatic stage
- •participants ineligible for restoration of gastrointestinal continuity
- •participants ineligible for surgery
- •participants ineligible for general anesthesia
结局指标
主要结局
Rate of efficacy of endoscopic gastrointestinal anastomoses using transmural self-expandable prostheses to restore the gastrointestinal continuity in patients after Hartmann procedure (Endo-HARP)
时间窗: 12 months
Evaluation of efficacy based on patency of endoscopic entero-rectal anastomosis confirmed radiologically and endoscopically. Unit of Measure: the number of participants with patency of endoscopic entero-rectal anastomosis compared to the total number of participants, who underwent endoscopic gastrointestinal anastomoses using transmural self-expandable prostheses to restore the gastrointestinal continuity in patients after Hartmann procedure (Endo-HARP)
Rate of complications during endoscopic gastrointestinal anastomoses using transmural self-expandable prostheses to restore the gastrointestinal continuity in patients after Hartmann procedure (Endo-HARP)
时间窗: 12 months
Evaluation of all complications in patients with endoscopic gastrointestinal anastomoses (Endo-HARP). Unit of Measure: the number of participants with complications compared to the total number of participants, who underwent endoscopic gastrointestinal anastomoses using transmural self-expandable prostheses to restore the gastrointestinal continuity in patients after Hartmann procedure (Endo-HARP).
次要结局
- Rate of early complications during endoscopic gastrointestinal anastomoses using transmural self-expandable prostheses to restore the gastrointestinal continuity in patients after Hartmann procedure (Endo-HARP)(30 days)
- Rate of late complications during endoscopic gastrointestinal anastomoses using transmural self-expandable prostheses to restore the gastrointestinal continuity in patients after Hartmann procedure (Endo-HARP)(12 months)
- Rate of clinical success of endoscopic gastrointestinal anastomoses using transmural self-expandable prostheses to restore the gastrointestinal continuity in patients after Hartmann procedure (Endo-HARP)(12 months)
- Rate of technical success of endoscopic gastrointestinal anastomoses using transmural self-expandable prostheses to restore the gastrointestinal continuity in patients after Hartmann procedure (Endo-HARP)(duration of procedure)
研究者
Mateusz Jagielski
Professor
Nicolaus Copernicus University
