Comparison of postoperative pain after needle grasper-assisted single-incision laparoscopic appendectomy versus single-incision laparoscopic appendectomy: a prospective randomized controlled trial (PANASILA trial)

Abstract

Purpose: This study was performed to compare the efficacies of newly developed needle grasper-assisted (Endo Relief) single-incision laparoscopic appendectomy (NASILA) and single-incision laparoscopic appendectomy (SILA).

Methods: This study enrolled 110 patients with acute appendicitis without periappendiceal abscess, diagnosed using computed tomography, who were randomized to the SILA (n = 54) and NASILA groups (n = 56) between December 2017 and August 2018 (6 patients withdrawn). The NASILA technique entailed a small umbilical incision for the glove port (equivalent to that for a 12-mm trocar), and a 2.5-mm suprapubic incision for the needle grasper.

Results: The SILA and NASILA groups included 49 (male, 61.2%) and 55 (male, 54.5%) patients, respectively. Age, body mass index, abdominal surgical history, symptom duration, and use of patient-controlled analgesia did not differ significantly between the 2 groups. The main wound size was significantly smaller in the NASILA group than in the SILA group (1.8 ± 0.4 cm vs. 2.2 ± 0.4 cm, P < 0.001). The operative time and estimated blood loss did not differ significantly between both groups. The immediate postoperative pain score, i.e., the primary endpoint, was significantly lower in the NASILA group than in the SILA group (2.33 ± 0.98 vs. 2.82 ± 1.29, P = 0.031). The complaints for scar status 1 month postoperatively did not differ significantly between the groups.

Conclusion: NASILA could attenuate postoperative pain by minimizing the size of the surgical wound; further, NASILA may not be inferior to SILA in terms of cosmetic results.

Keywords: Appendectomy; Laparoscopy; Surgical instruments; Surgical wound.

Fig. 1. Single-incision laparoscopic appendectomy. (A) An about 2.5-cm transumbilical incision is made. (B) Glove port (NELIS Corp., Bucheon, Korea) was introduced through the umbilical incision. Laparoscopy (5 mm) and instruments were introduced through the glove port. (C) About 2.5 cm-sized wound at the end of the operation. (D) A scar on postoperative 1 week.

Fig. 2. Characteristics of needle grasper (Endo Relief, Hirata Precisions Corp., Kamagaya, Japan). (A) The needle grasper consists of 3 parts. One is the shaft and the jaws, it has a handle, and there is a part that connects the 2 parts. The shaft is 2.4-mm thick and the jaws are the same as the jaws of the 5-mm instrument. (B) It is used by assembling 3 parts. It is joined after passing through the abdominal wall for mounting through a small wound in the abdominal wall. (C) A guide tube enters through the abdominal wall and exits through the trocar. Align the guide tube with the needle grasper so that the handle side of the needle grasper's shaft comes out through the abdominal wall. (D) The guide tube is separated from the needle grasper. (E) The handle is connected, and the needle grasper is ready to use. (F) The needle grasper can handle tissue like any other 5-mm instrument.

Fig. 3. Needle grasper-assisted single-incision laparoscopic appendectomy. (A) Small umbilical incision in which only a 12-mm trocar can be loaded is made. The arrow is a 12-mm reusable trocar. (B) Pediatric glove port (NELIS Corp., Bucheon, Korea) is applied, and a needle grasper is introduced on the suprapubic area through a 2.5-mm wound. (C) About 1.3-cm main wound and about 3-mm needle grasper site wound at the end of the operation. The arrow is the wound for the needle grasper. (D) Scar on postoperative 1 week. The arrow indicates scar of the wound for the needle grasper.

Fig. 4. CONSORT (Consolidated Standards of Reporting Trials) flow. SILA, single-incision laparoscopic appendectomy; NASILA, needle grasper-assisted single-incision laparoscopic appendectomy.

Fig. 5. Degree of postoperative pain. IPOP, immediate postoperative (pain score right after transfer to the ward from the operating room); MAX#, maximum pain score at postoperative day #; SILA, single-incision laparoscopic appendectomy; NASILA, needle-assisted single-incision laparoscopic appendectomy.