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Hernia (2009) 13:275–280DOI 10.1007/s10029-008-0469-7 123 ORIGINAL ARTICLE Incisional hernia after upper abdominal surgery: a randomisedcontrolled trial of midline versus transverse incision J. A. Halm · H. Lip · P. I. Schmitz · J. Jeekel Received: 17 August 2008 / Accepted: 12 December 2008 / Published online: 4 March 2009 © The Author(s) 2009. This article is published with open access at Springerlink.com Abstract Objectives To determine whether a transverse incision isan alternative to a midline incision in terms of incisionalhernia incidence, surgical site infection, postoperative pain,hospital stay and cosmetics in cholecystectomy. Summary background data Incisional hernias after mid-line incision are commonly underestimated but probablycomplicate between 2 and 20% of all abdominal wall clo-sures. The midline incision is the preferred incision for sur-gery of the upper abdomen despite evidence thatalternatives, such as the lateral paramedian and transverseincision, exist and might reduce the rate of incisional her-nia. A RCT was preformed in the pre-laparoscopic chole-cystectomy era the data of which were never published. Methods One hundred and W fty female patients were ran-domly allocated to cholecystectomy through midline ortransverse incision. Early complications, the duration todischarge and the in-hospital use of analgesics was noted.Patients returned to the surgical outpatient clinic for evaluationof the cosmetic results of the scar and to evaluate possiblecomplications such as W stula, wound dehiscence and inci-sional hernia after a minimum of 12 months follow-up. Results Two percent (1/60) of patients that had undergonethe procedure through a transverse incision presented withan incisional hernia as opposed to 14% (9/63) of patientsfrom the midline incision group ( P =0.017). Transverseincisions were found to be signi W cantly shorter than mid-line incisions and associated with more pleasing appear-ance. More patients having undergone a midline incision,reported pain on day one, two and three postoperativelythan patients from the transverse group. The use of analge-sics did not di V er between the two groups. Conclusions In light of our results a transverse incisionshould, if possible, be considered as the preferred incisionin acute and elective surgery of the upper abdomen whenlaparoscopic surgery is not an option. Keywords Cholecystectomy · Hernia abdominal ·Abdominal wall Introduction The rate of incisional hernia after midline incision is com-monly underestimated but probably lies between 2 and 20%[1–5]. Thus, incisional hernia is a major postoperative problem. The treatment of incisional hernia is complicatedby high rates of recurrences. Recently, in a randomisedcontrolled trial published by Burger etal. [6], midline inci-sional hernia repair has been shown to be associated with a10-year cumulative recurrence rate of 63 and 32% forsuture and mesh repair, respectively.The midline incision is the preferred incision for surgery of the upper abdomen, despite evidence that alternatives, such as J. A. Halm · J. JeekelDepartment of General Surgery, Erasmus MC,University Medical Center Rotterdam, Dr. Molewaterplein 40,3015 GD Rotterdam, The NetherlandsH. LipDepartment of Anesthesiology,Sophia Hospital, Zwolle, The NetherlandsP. I. SchmitzDepartment of Trials and Statistics, Erasmus MC,University Medical Center Rotterdam,Groene Hilledijk 301, 3075 EA Rotterdam, The NetherlandsJ. A. Halm ( & )Department of Surgery, Ikazia Hospital,Montessoriweg 1, 3083 AN Rotterdam, The Netherlandse-mail:
[email protected] 276Hernia (2009) 13:275–280 123 the lateral paramedian and transverse incision, exist and mightreduce the rate of incisional hernia [7]. Various approaches toopening the abdomen have been advocated over time. Thechoice for a certain incision is dependent on the exposure nec-essary for the desired procedure to succeed. A midline inci-sion, be it supraumbilical, infraumbilical or both, is anapproach especially suited for emergency and exploratorysurgery because of the quick and generous exposure that canbe achieved within a few minutes [8,9]. The avascular nature of the linea alba minimises blood loss during this procedure.A supraumbilical transverse incision may be utilised in caseexposure of the upper abdomen is desired. During this inci-sion, the damage in X icted to the segmental arteries and nervesis previously described as being minimal [10]. Previously,only one randomised controlled trial, comparing transverseand true midline incisions, has been published speci W callyaddressing incisional hernia incidence [11].To determine whether the use of a transverse incision isan alternative to a midline incision for open cholecystec-tomy in terms of incisional hernia incidence, surgical siteinfection, postoperative pain and hospital stay, thisrandomised controlled trial was performed. This trial wasconducted in an era when laparoscopic cholecystectomywas not yet available. The possibility of low incisional herniarates after transverse incisions and the fact that little isknown about potential advantages incited us to publish therelevant results of this randomised controlled trial whichhas been performed in the past and has only been reportedin a Dutch thesis by one of the authors (H.L.). The primaryendpoint of this study was the incisional hernia incidenceafter 12months of follow-up. Secondary endpointsincluded pain and cosmetic appearance. Methods ProtocolSome 150 consecutive female patients were randomlyassigned to a midline or transverse incision as an approachfor elective cholecystectomy or combined cholecystectomyand cholangiography (with or without consecutive choledo-chotomy) (75 and 75 patients, respectively). Emergencyprocedures were excluded from participation. The samplesize is based on an incisional hernia rate reduction from 20to 6% at a power of 80% and an error rate of 5%.Obtaining informed consent was conducted in accor-dance with the ethical standards of the Helsinki Declarationof 1975. The investigation reported was performed withinformed consent from all of the patients and followed theguidelines for experimental investigation with human sub- jects and was approved by the medical ethics committee.An independent statistician prepared closed, tamper-proof envelopes containing the random allocation (Fig.1).Patients were randomised for one of the procedures in the-atre through the opening of the envelopes.Patient-related factors that were recorded were age, bodymass and length and date of operation. Operation-relatedfactors that were recorded were the exact nature of theoperation, length of the incision, the thickness of the subcu-taneous fat, surgeon performing the procedure, as well asthe duration of the operation (skin-to-skin time). In theimmediate postoperative period, the use, dose and type of analgesics was recorded and a pain score was administered.The use of analgesics (morphine 7.5mg intra-muscular injec-tion, 4h minimum interval between consecutive injections) Fig.1 Flow chart of patientinclusion and follow-up Informed consent(N=150)ConcealedRandomized (N=150)Midline incision(N=75)Received allocatedintervention (N=75)Follow up achieved(N=63)Follow up achieved(N=60)Withdrawn from follow-up after surgery hadbeen performed(N=1)Transverse incision(N=75)Received allocatedintervention (N=75)Analyzed(N=63)Analyzed(N=60) Hernia (2009) 13:275–280277 123 was monitored for 48h after surgery; the pain score wasadministered for the W rst 6days after surgery.In patients assigned to surgery through a midline inci-sion, the skin was incised from just below the xyphoid pro-cess to just above the umbilicus. The abdominal wall wasopened in the midline by incising the linea alba. A Collintype (two-bladed) self-retaining retractor was used to main-tain exposure. The abdominal wall was closed in one layerusing single polygalactin 910 sutures (Vicryl; Ethicon,Amersfoort, The Netherlands). The skin was consequentlyclosed using running mono W lament nylon sutures (Ethilon;Ethicon, Amersfoort, The Netherlands).Patients randomised for a transverse incision received aright-sided unilateral transverse incision between 3 and4cm below the costal margin. The rectus muscle wasincised. The W bres of the external and internal obliques andthe transverse muscles were separated in the direction of their course. Exposure was achieved through the use of amanually held single-bladed retractor. Closure of theabdominal wall was achieved by closure of the peritoneumand the posterior rectus fascia using a continuous, polygal-actin 910 suture (Vicryl; Ethicon, Amersfoort, The Nether-lands). The anterior rectus sheath and the fascia of theinternal and external transverses were closed using simpleinterrupted polygalactin 910 sutures (Vicryl; Ethicon,Amersfoort, The Netherlands). Towards the end of bothprocedures, a Redon low-vacuum drain catheter wasplaced, which was guided outside the abdominal cavityapproximately 5cm from the incision. The skin was conse-quently closed using continuous mono W lament nylon suture(Ethilon; Ethicon, Amersfoort, The Netherlands). Allpatients received a dose of 5,000IU of sodium–heparin onthe morning of the procedure as thrombosis prophylaxis.Statistical analysisThe Pearson 2 test was used for comparing percentages. Incase of small expected numbers, a Fisher’s exact test wasperformed. Continuous variables were analysed using theMann–Whitney test. A P -value of 0.05 or less (two-sided)was considered to be statistically signi W cant. Means andmedians are expressed § standard deviation (SD).Follow-upPatients returned to the surgical outpatient clinic for evalua-tion of the cosmetic results of the scar and to evaluate pos-sible complications, such as W stula, wound dehiscence andincisional hernia, after a minimum of 12months follow-up.The patient and the surgeon evaluated the cosmetic resultsindependently and were asked to rate the scar as unsatisfac-tory, satisfactory or W ne. Furthermore, the length and widthof the scar was measured. Results Study groupSome 150 consecutive patients were randomised forparticipation in this study during an inclusion period fromApril 1977 until July 1979. Seventy- W ve patients received atransverse incision and 75 patients a midline incision (Fig.1).One patient was withdrawn from further follow-up afterdeveloping peritonitis and consequent acute respiratory dis-tress syndrome (ARDS) not related to the closure of theabdominal wall 2days after surgery (transverse incisiongroup).The patients’ average age was 51.9 and 51.4years forthe midline and the transverse incision groups, respectively.Furthermore, no di V erences were found in the body massand average length between the two groups (Table1). Acholecystectomy was performed using a transverse incisionin 52 patients and utilising a midline incision in 52 patientsalso. Fifteen and 16 patients, respectively, underwent acombined cholangiography/cholecystectomy. A further 7and 6 patients, respectively, were treated with a cholangi-ography/cholecystectomy plus additional choledochotomyand the postexploratory placement of a T-tube.SurgeonSta V surgeons performed 17% (13/75 patients) of all proce-dures performed through a midline incision. The remainderof the procedures through a midline incision was carriedout under sta V surgeon supervision. Sta V surgeons per-formed 14% of all procedures in the transverse incisionsstudy group (10/74 patients) and supervised the remainder.No statistically signi W cant di V erence was found betweenthe two randomised groups ( P =0.65).Duration of surgeryNo signi W cant di V erence was noted in the skin-to-skin time(in min) for the two di V erent incisions (Table2). Surgeryutilising midline and transverse incision took 56.9 § 29.3and 53.2 § 26.8min, respectively ( P =0.35). The totalduration of the procedures until extubation (in min) did not Table1 Baseline characteristics of the patients undergoing surgery,according to study groupVariableMidline incisionTransverse incision n =75 n =74Average age (years) § SD51.9 § 14.851.4 § 13.8Average weight (kg) § SD71.3 § 14.568 § 14.3Average length (cm) § SD163.5 § 7.8164 § 7.3 278Hernia (2009) 13:275–280 123 di V er between the midline and transverse incisions(71.0 § 30.5 and 67.0 § 27.3, respectively, P =0.34).Pain and analgesicsSigni W cantly more patients, having undergone a midlineincision, reported pain on day one, two and three postopera-tively ( P <0.0001, Table3). In the midline incision group,28/75 patients required no or only one dose of analgesics;the remainder required two or more doses. Thirty-onepatients operated through a transverse incision required noanalgesics or only one dose; 43 patients (the remainder)required two or more. No signi W cant di V erence in the use of analgesics was found between the groups ( P =0.69).ComplicationsPostoperative complications (Table4) were seen in 16 outof 75 patients (21%) from the midline incision group and in15% from the transverse incision group (11 patients)( P =0.30). Brie X y, one patient in each group developedcardiac complications; 8 and 6 patients developed urinaryretention after the midline and transverse incisions, respec-tively ( P =0.59). Surgical site infections were diagnosed in7 and 3 patients, respectively ( P =0.33).DischargeForty- W ve (60%) and 42 (57%) patients from the patientshaving undergone a midline or a transverse incision,respectively, were discharged on day 6 or 7 postopera-tively. The remaining patients from each group left hospitalcare on day 8 or later. The duration of hospital admissiondid not di V er between the two types of incision ( P =0.74).CosmeticsThe width and length of all incisions was measured duringthe follow-up visit (Table2). The mean width of the scarafter the healing of the midline incisions was found to be8.3 § 1.4 mm. The mean width of the scar after the healingof the transverse incisions was measured to be 3.3 § 1.2mm. This observed di V erence is signi W cant ( P <0.0001).The length of the incisions was 140 § 24 mm and 164 § 28mm for the transverse and the midline incisions, respec-tively. The di V erence in scar length was found to be signi W -cant ( P <0.0001). Follow-up Eighty-one percent of all patients operated through a trans-verse incision were seen during the follow-up examination( n =60). Of the patients operated through a midline inci-sion, 63 out of 75 were seen at the outpatient clinic (84%).The patients that were lost to follow-up could either not betraced or had deceased (Fig.1). The minimum follow-up Table2 Length of incision, thickness of subcutaneous fat and skin-to-skin time, according to study group a Measured during surgery in 75 midline and 74 transverse incisions b Measured at follow-up in 63 and 60 midline and transverse incisions,respectivelyVariableMidlineincisionTransverseincision P -valueLength of incision(mm) § SD a 164 § 28140 § 24<0.0001Thickness of subcutaneousfat (mm) § SD a 34.5 § 13.030.3 § 12.40.05Skin-to-skin time(min) § SD a 56.9 § 29.353.2 § 26.80.40Width of scar(mm) § SD b 8.3 § 1.43.3 § 1.2<0.0001 Table3 Postoperatively reported pain, according to study group,shown as the number of patients reporting pain at the time points indi-cated (percentage), with the remainder of patients reporting no painTime pointafter surgeryMidline incision n =75Transverse incision n =74 P -valuePatients reportingpain, n (%)Patients reportingpain, n (%)3–4h68 (91)60 (81)0.09First day64 (85)39 (53)<0.0001Second day57 (76)23 (31)<0.0001Third day28 (37)9 (12)<0.0001Fourth day5 (7)3 (4)0.72Fifth day0 (0)1 (1)0.50Sixth day0 (0)1 (1)0.50 Table4 Rate of complications after surgery, according to studygroup, shown as the number of patients diagnosed with complications(percentage)ComplicationMidlineincisionTransverseincision P -value n =75 n (%) n =75 n (%)Cardiac1 (1)1 (1)1Urinary retention8 (12)6 (8)0.59ARDS01 (1)0.50Surgical site infection7 (9)3 (4)0.33Haemorrhage1 (1)00.50Pneumonia01 (1)0.50Total17 (23)12 (16)0.30
