經鼠蹊腹膜前改良式Kugel網膜的長期併發症 - 單盲隨機分對照研究
Long-term complication following trans-inguinal preperitoneal Modified Kugel mesh herniorrhaphy - A single blind prospective randomized controlled trial
Pao-Hwa Chen1, Heng-Chieh Chiang1, Yao-Li Chen2,
Bai-Fu Wang1, Jesun Lin1, Jian-Ting Chen1, Yu-Chi Hsu1,
1Divisions of Urology, Department of Surgery, Changhua Christian Hospital, Changhua, Taiwan
2Transplant Medicine and Surgery Research Center, Changhua Christian Hospital, Changhua, Taiwan
陳柏華、江恆杰、陳堯俐、王百孚、林介山、陳建廷、許玉琦
1彰化基督教醫院 外科部 泌尿科
2彰化基督教醫院 外科部 器官移植中心
Objective: In the initial retrospective review, safety and efficacy of the single layer per-peritoneal placement of Modified Kugel (MK) mesh were analyzed. Due to the fear of recurrence, optional on-lay is routinely used in the preliminary introduction of MK mesh. After analyzing the pre-peritoneal placement and reduction of patient complains after omitting the on-lay patch, a randomized controlled trial was designed to evaluate the necessity of the on-lay patch in protecting future recurrence compared to single layer pre-peritoneal mesh placement and identify any counter-productive effects of using on-lay mesh in inguinal herniorrhaphy.
Materials and Methods: After obtaining institutional board approval, we randomized 100 patients into two groups. A single surgeon (H.C.C.) will perform the same operation placing the pre-peritoneal mesh on both group, with the only difference being the placement of optional on-lay mesh on the study group. One researcher (V.H.) would perform post-operative interview with series of questions at 1, 3, 6, 12 months. Another researcher (P.H.C.) will organize and perform statistical analysis of the peri-operative and post-operative data.
Results: The age, BMI, male/female ratio were similar between the two group. During long term follow-up, two patients in 1-layer group and 1 patient in 2-layer group were lost during follow-up. The post-op pain, numbness and soreness were similar. No foreign body sensation was noted for the 1-layer after >3 months. No recurrence was noted during our follow-up period.
Conclusion: An adequate dissection of the pre-peritoneal space will ensure placement of mesh in the similar location as laparoscopic herniorrhaphy. Single layer trans-inguinal pre-peritoneal mesh placement is not at risk of future recurrence events when compared with two-layer mesh herniorrhaphy. With decrease of materials inserted in the inguinal canal, the inflammatory response in the inguinal canal will be much less prominent with the surrounding tissues and nerves.