Clinical trial NCT05781932: Innovative Suture Technique for Endoscopic Hernia Incision
Official title: Effects of Barbed Suture Continuous Tension Reduction Suture in Dermal Combined With Epidermal Glue on the Healing of Endoscopic Stuck Hole and Scar Formation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suture Techniques
Medical Glue
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2023-03-23
Enrollment: 100
Sex: ALL
Minimum age (years): 46
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The minimally invasive surgical technique represented by endoscopy is one of the most important inventions in the medical field of the 20th century. Laparoscopic surgery is a technique in which a rod-shaped camera and special surgical instruments are inserted into the body cavity (abdominal cavity, chest cavity, etc.) to complete the surgical operation by poking 3-4 holes (0.5-2 cm in size) in the body wall\[2\]. These holes are known as poke holes, and the closure of poke holes is a technique that every young surgeon must master. Currently, the proportion of endoscopic minimally invasive surgeries, including inguinal hernia repair, has increased widely in China. Currently, most of inguinal hernia repairs at our center are performed laparoscopically. Shortening the suture time and healing time of the stuck hole, improving the healing strength of the skin, and reducing scar hyperplasia are issues worth discussing.

Barbed sutures were first used in plastic surgery and are now widely used in laparoscopic tissue suturing. Because it is knot-free and one-way tightening, the tension of the incision can be released evenly, avoiding excessive local tension in the incision and causing ischemia and necrosis, which in turn affects the healing of the incision. Barbed thread sutures can be used to quickly close the incision and achieve excellent results. A good incision reduces tension and prevents scarring. Medical glue can quickly form a thin waterproof film on the surface of an incision, which promotes blood coagulation, wound shrinkage, and sealing.

Inguinal hernia is a common and frequently occurring condition. Minimally invasive surgery for an inguinal hernia can reduce postoperative pain, help patients resume daily activities early, and achieve rapid recovery; therefore, it is being accepted by an increasing number of people\[12\]. After laparoscopy, the treatment of poking holes is an indispensable part of surgery and is directly related to postoperative recovery, aesthetics, and patient satisfaction. Combining the continuous tension reduction suture of the dermis barbed suture with epidermis glue should help achieve better incision healing, reduce incision scars, and simultaneously return to daily activities faster, shower after surgery, and improve the medical treatment experience. This is the first study to try this novel approach.

A total of 100 patients who underwent laparoscopic total extraperitoneal (TEP) inguinal hernia repair in the General Surgery Department of Zhongshan Hospital Affiliated with Xiamen University from January 2022 to May 2022 were selected as the research subjects. They were randomly divided into two groups; the traditional Vicryl interrupted suture was used to poke the hole (control group), and the dermis barbed suture was used for continuous tension reduction suture combined with the epidermis glue to poke the hole (experimental group). Statistical differences were compared between the two stitching methods regarding operation time, incision healing, incision healing scars, and incision complications.


Eligibility criteria: Inclusion Criteria:

* (1) outpatients diagnosed with inguinal hernia by color Doppler ultrasound or CT examination and
* (2) signed informed consent.

Exclusion Criteria:

* (1) other serious diseases of the system, such as severe cardiopulmonary dysfunction and liver and kidney insufficiency;
* (2) obvious abnormal coagulation function;
* (3) history of open lower abdominal surgery;
* (4) inability to complete follow-up or treatment compliance;
* (5) high risk of incision infection.

Primary outcomes:
measure: During surgery
timeFrame: The time required to close the abdominal wall incision
measure: Surgical incision healing
timeFrame: 2 weeks after the operation,
measure: Scar scoring
timeFrame: Three months after the operation,
measure: Pain score:
timeFrame: 1 week after the operation
Secondary outcomes:
Other outcomes:
Locations:
city: Xiamen
country: China
facility: Yizhuo Lu
state: Fujian
Study officials:
References: