Comparison of Post-operative Pain in Short Versus Long Stitch for Laparotomy Closure

NCT03828409 | Completed

• 1 other identifier: NMRR-16-1892-32723
• Study Type: interventional
• Target: 86
• Locations: 0 countries
• Sites: N/A

Brief Summary

Laparotomy is a surgical procedure where an incision is made through the abdominal wall in order to gain access to the peritoneal cavity. Midline laparotomy incisions were the main type of abdominal access. However, there were complications associated with laparotomy such as incisional hernia, post-operative pain, surgical site infection and burst abdomen. The anterior abdominal wall consists of skin, fascia, subcutaneous fat, external oblique aponeurosis, internal oblique muscles, transversus abdominis and rectus muscles. The skin and parietal peritoneum are supplied by T7- T12 and L1 nerve. Hence, breaching of the peritoneum, giving rise to post-operative laparotomy pain. It is reported that approximately 60% of patients who underwent laparotomy do complain of post-operative pain. Techniques of abdominal wall closure has been constantly in order to develop an ideal suture technique to minimise wound complications. One of the most significant changes in abdominal closure technique was the introduction of mass closure technique, known as 'long stitch' (LS). This conventional mass closure, uses a suture-to-wound length ratio (SL:WL) of 4:1, achieved by the use of continuous sutures at one centimetre from rectus edge with inter-suture distance of one centimetre. Studies have shown LS caused compression of tissues enclosed in the mass stitch, leading to tissue ischaemia and necrosis. 'Short stitch' (SS) was introduced in 1980s where it was reported to result in lower rate of incisional hernia and surgical site infection. It has a SL:WL of more than four, achieved by placing the suture five millimetres from rectus edge with inter-suture distance of five millimetre as well. It incorporates only the linea alba, which may reduce tension and post-operative pain.Studies has indicate that approximately 40% of post-operative patients reported inadequate pain relief despite therapeutic intervention. Inadequate pain control is associated with complications such as atelectasis, prolonged immobilization and hospital stay, thromboembolic event, cardiac morbidity, insomnia, ileus and poor wound healing The Visual Analog Scale (VAS) of pain is commonly used as measures of pain score or intensity in clinical trials. A more objective way to evaluate the post-operative pain is to assess the usage of patient-controlled analgesia (PCA) over a period of time. The commonly used PCA drug for post-operative patient is morphine. As SS relies on less tension and proper distribution of force along the fascial plane, it is possible that it might reduce post-operative pain as compared to LS technique. It can be assessed using total usage of analgesia (intravenous infusion or PCA), with correlation to the respective visual-analogue scales (VAS) or numeric rating scales (NRS) at that particular time. There is no study that evaluate post-operative pain difference between SS and LS technique. The hypothesis of this study is that SS will reduce PCA morphine usage after midline laparotomy, which translate into reduction in post-operative pain. In order to detect the 30% reduction of PCA morphine, 86 patients are required.

Conditions

Pain, Postoperative

Keywords

short stitch; post-operative pain; PCA morphine usage; elective midline laparotomy

Outcome Measures

Primary Outcomes (1)

• Reduction of PCA morphine usage post-operatively

  Measure total usage of PCA morphine

  24 hours

Secondary Outcomes (2)

• Presence of Surgical site infection

  throughout hospital stay, 2 weeks, 6 weeks and then 8 weeks during follow up (up to 1 year)

• Length of hospital stay

  since day 1 hospital admission until the time when patient is deemed fit to be discharged (up to 1 month)

Study Arms (2)

Short stitch

ACTIVE COMPARATOR

short stitch used as one arm

Procedure: Short stitch; Procedure: Long stitch

Long stitch

ACTIVE COMPARATOR

Long stitch as conventional mass-closure technique

Procedure: Short stitch; Procedure: Long stitch

Interventions

Short stitch PROCEDURE

The rectus sheath are cleaned off the subcutaneous fats. Short stitch technique uses smaller needle and suture material. The suture is placed nearer to each other as compared to our conventional long stitch technique. It has inter-suture distance of 5mm and 5mm distance from rectus edge. The suture will be started at one end and sutured continuous until the other end. Hence, this technique is applied without tension.

Long stitch; Short stitch

Long stitch PROCEDURE

Long stitch uses a larger needle and suture material. The suture is placed 1cm from the linea alba and 1 cm from previous suture. This technique include mass closure sutures at the midline laparotomy

Long stitch; Short stitch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective primary midline laparotomy,
• ASA Class I to III
• hemodynamically stable
• able to provide consent for surgery

You may not qualify if:

• Emergency laparotomy
• pregnancy
• history of previous midline laparotomy
• allergic to opiates
• unable to use PCA morphine (handicapped)
• patient will be planned for stoma creation

Sponsors & Collaborators

• University of Malaya: lead

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patient will not know what technique was used for the abdominal wall closure. The medical officers that will assess patient's PCA morphine usage and VAS score post-operatively will not know which technique of suturing was used for that particular patient.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized into two arms (short stitch: SS and long stitch:LS).The LS belongs to our conventional mass closure technique for midline laparotomy. SS technique has been used to investigate other parameters such as surgical site infection and incisional hernia. This study is carried out to evaluate if SS technique will reduce post-operative pain.

Study Record Dates

• First Submitted: January 28, 2019
• First Posted: February 4, 2019
• Study Start: January 1, 2017
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: February 4, 2019

Record last verified: 2019-01