Parastomal Hernia Prevention: Longitudinal Incision Versus Cruciate Incision in the Construction of an End Colostomy. LONG CROSS Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- parastomal hernia rate by imaging
研究概览
简要总结
TITLE:
"Incidence of parastomal hernia: Randomized clinical trial comparing the longitudinal fascial incision (" Hepworth hitch ") vs. cruciate incision in the exteriorization of a end colostomy ".
DESIGN:
Randomized, open and parallel clinical trial so patients will be assigned to the cruciate incision group or longitudinal incision with a 1: 1 allocation ratio.
POPULATION:
Patients undergoing colorectal cancer surgery a definitive end colostomy.
OBJECTIVES:
The main objective is to compare the parastomal hernia rate diagnosed by imaging at 2 years after surgery.
Secondary objectives are:
- Clinically relevant parastomal hernia rate by physical examination 2 years after surgery.
- Incidence of postoperative complications related to the stoma (dehiscence, retraction, stenosis, necrosis, surgical revision, prolapse and special needs of care of the stoma in the immediate or late postoperative period); 3) Incidence of postoperative complications assessed according to the Comprehensive Complication Index (CCI) scale.
- Ease / difficulty in the management of stomatherapy devices by patients using VAS (Visual Analogue Scale).
DESCRIPTION OF THE INTERVENTION:
An end colostomy without placement of a prophylactic mesh will be performed in all patients. In the group 1A, a longitudinal incision will be made in the anterior rectus fascia and in the posterior fascia, with two Prolene sutures at the ends of the incision of the anterior aponeurosis. In patients of group 1B, a cruciate incision will be made in the anterior rectus fascia, as well as in the posterior fascia.
DURATION OF THE STUDY:
The expected duration of the study is 3 years.
PATIENT FOLLOW UP TIME:
The planned follow-up time is 2 years.
EXPECTED RECRUITMENT TIME:
12 months.
详细描述
Parastomal hernia is one of the major complications after definitive terminal colostomy in patients with colorectal cancer, which is clinically relevant in up to 50% of the cases but can reach 78% of cases when radiologically identified. Although the majority of cases are asymptomatic, 26-30% of patients will require surgical intervention of the parastomal hernia for their symptoms, obstruction, incarceration, prolapse, leaks or aesthetic reasons.
Traditionally, the colostomy is made with a circular skin incision, dissection of the subcutaneous fat to the fascia and an incision of approximately 3 cm longitudinal and approximately 2 cm transversely. The anterior rectus muscle is loosened in the direction of the fibers and another cross incision is made in the posterior fascia to subsequently externalize the colon. The colostomy is fixed to the skin using mucocutaneous stitches of absorbable suture.
The hypothesis is that the longitudinal incision technique supplemented with Prolene stitches at the upper and lower ends of the incision acts as a "barrier" for the expansion of the hernia.
We designed a clinical trial to study the prevention of parastomal hernia with a simple modification such as making a vertical incision associated with four prolene stitches at the ends of incision, with minimal morbidity and an easy technique. The objective of the study is to analyze the postoperative parastomal hernia rate compared to the conventional technique (crossed incision).
JUSTIFICATION:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
computer based aleatoric numbers
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing surgery for colorectal cancer undergoing definitive end colostomy.
- •Age ≥ 18 years and <85 years.
- •Any type of tumor, any T, N, M
- •Consent signed by the patient and by the researcher.
排除标准
- •no colostomy, not end stoma.
- •Inflammatory bowel disease with anatomopathological confirmation.
- •Patients with previous incisional hernias or carriers of meshes except inguinal hernioplasties.
- •Patients with previous stoma.
- •Inability to read or understand any of the languages of informed consent.
- •Emergency surgery.
- •Psychiatric diseases, addictions or any disorder that prevents the compression of informed consent.
- •Extraction of the piece by colostomy hole.
- •Colostomies not previously marked by specialized stomatherapist.
结局指标
主要结局
parastomal hernia rate by imaging
时间窗: 2 years
parastomal hernia by CT
次要结局
- Clinically relevant parastomal hernia rate(2 years after surgery)
- Incidence of postoperative complications related to the stoma (dehiscence, retraction, stenosis, necrosis, surgical revision, prolapse and special needs(2 years)
- Ease / difficulty in the management of stomatherapy devices(2 years)
研究者
Prof. Jose M Enríquez-Navascués
Professor
Hospital Donostia