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DGHAL with recto-anal-repair modification:

functional evaluation and safety assessment of a

new minimally-invasive method of treatment of

advanced hemorrhoidal disease

Piotr Walega MD, PhD, Michal Romaniszyn MD, Jakub Kenig MD, PhD, Roman

Herman* Prof, Wojciech Nowak Prof

3rd Department of General Surgery, Jagiellonian University School of Medicine,

Pradnicka Str. 35-37 31-202, Krakow, Poland

*Department of Experimental and Clinical Surgery, Institute of Physiotherapy, Jagiellonian University

School of Medicine, Michalowskiego Str. 12, 31-126 Krakow, Poland

Phone: +48126331995

Fax: +48126333105

Email: pwalega@mp.pl



Abstract



PURPOSE: The aim of this paper is to present 12-month follo w-up results of functional evaluation and

safety assessment of an innovative modification of hemorrhoidal artery ligation (DGHA L) called Recto -

Anal-Repair (RAR) in the treatment of IIIrd and IVth grade hemorrhoidal disease (HD), conducted in the

3rd Depart ment of General Surgery, Jagiellonian University. M ETHODS: A total of 38 patients with grade

III and IV HD underwent the RAR procedure consisting of Doppler Guided Hemorrhoid Artery Ligation

combined with restoration of the prolapsed hemorrhoids to their anatomical position with longitudinal

continuous sutures. Each patient had a rectal examination, anorectal manometry and Quality of Life

questionnaire performed before, 3 months, and 12 months after the RAR procedure. RESULTS: Of the

initial 38 patients 18 were lost to follow-up. A mong the rema ining 20 patients, there were three cases

(15%) of intraoperative and one (5%) of early postoperative bleeding. 3 months after RAR 5 cases of minor

residual mucosal prolapse were detected (25%), wh ile on ly 3 patients (15%) reported persistence of some

symptoms. 12 months after RAR another 3 cases of hemorrhoid disease recurrence were detected, to a total

of 8 patients (40%) with minor HD recurrence 12 months after RA R. Anal p ressure levels 3 months after

RAR were significantly lower than before the procedure (p0.05).





Table 1.

Grade (Parks)

n Mean age III III/IV IV

Male 12 54 (29-70) 3 6 3

Female 8 56 (40-68) 6 1 1





The RAR procedure itself took about 35 minutes on average (25-75) from beginning of

anesthetical procedures to transportation of the patient back to bed from the operating

table. Mean number of arteries ligated during the procedure was 5,65 (4-8), most

frequently found on 1 and 11 o'clock (in Loyd-Davis’ position, corresponding to 5 and 7

o’clock in supine position). There were on average 2,5 (1-4) longitudinal sutures used to

pull prolapsed mucosa up into the anal canal. There were three cases (15%) of

intraoperative bleeding requiring additional haemostatic sutures. Early postoperative

bleeding (approximately 60 ml of blood) was reported in one patient (5%), on the first

day after surgery. The bleeding was successfully managed with sterile anal tamponade

(Lockhart-Mummary type). There were no other complications in perioperative period

which would require surgical intervention. Postoperative pain was easily managed with

NSAIDs administered i.v. or p.o.

In the follow-up examination 3 months after RAR procedure there were 5 cases (25%) of

minor residual hemorrhoidal prolapse among the 20 patients included in the final

analysis, while only 3 of them (15%) reported residual symptoms (painful defecation and

itching). These 3 patients were all among the first 10, who underwent Recto-Anal Repair

in our Department. There were no cases of persistent bleeding within the first 3 months

after RAR procedure.







6

In anorectal manometry assessment, anal pressure levels recorded 3 months after RAR

were significantly lower than before the procedure (Table 2). On average BAP dropped

11,53%, SAP 12,2% in women, BAP dropped 5,82% and SAP 6,03% in men (p0,05).



Table 2. Mano metric findings upon qualificat ion and 3 months after DGHA L-RA R procedure

Mean BAP Mean SAP Physiological RSCC present

upon 3 months 12 months upon 3 months 12 months RAIR (before/after)

qualification after RAR after RAR qualification after RAR after RAR (before/after)

Male 78,83 72,17 67,92 214,50 199,75 198,75 12/ 12 12/ 12

Female 64,50 56,50 58,75 129,38 111,25 119,38 8/8 8/8







Based on the Quality of Life questionnaires (GIQL, FIQL), most of the patients (95%)

were satisfied with the results of the treatment, reporting better overall wellness and self-

confidence, despite of non complete reduction of mucosal prolapse in a few cases.

However, one of the 20 patients (5%), 73 year old male, reported occasional continence

problems at the follow-up examination 3 months after the procedure (incontinence of

gases, occasional soiling), with onset about one month after surgery. Manometric

findings were also normal in this patient. Change of diet and simethicone administration

three times a day was sufficient to relieve the patient’s symptoms.

In the follow- up examination 12 months after RAR procedure there were 3 new cases of

hemorrhoidal prolapse recurrence, giving a total of 8 known patients with hemorrhoidal

prolapse 12 months after the procedure. There were no cases of persistent bleeding, and

the satisfaction level measured with quality of life questionnaires was still high in most of

the patients (95%).

In anorectal manometry assessment, anal pressure levels recorded 12 months after RAR

were similar to values recorded 3 months after the procedure in the same patients

(p>0,05). There were no new cases of functional disorders recorded, the patient who

reported incontinence after the procedure, reported at the 12- month follow-up slight

improvement, with persistence of gases incontinence.





Discussion



Is it estimated that up to 75% of professionally active people suffer from hemorrhoidal

disease (HD). The prevalence of this complaint in the overall population might be even



7

higher, as many patients are too ashamed to visit a doctor or are afraid of conventional,

painful procedures with long recovery.

The researchers are in a constant search of new methods of treating hemorrhoidal disease

that would offer not only high effectiveness and low morbidity, but also short recovery

and good postoperative comfort. Rubber band ligation used in stage II and III

hemorrhoids can be complicated by post-procedure bleeding in up to 5% of cases[9]. The

efficacy of this method is 76% in stage II, 66% in stage III, and less then 20% in IV

degree hemorrhoids. Rubber band ligatures are placed under limited visual control, near

the dentate line; heamorrhoidal arteries are left open, which results in a high probability

of recurrence[10]. Baron’s method also requires several applications of rubber bands

since most of proctologists refrain from ligation of all hemorrhoidal piles during one

procedure. Moderately invasive methods such as Longo’s operation are burdened with a

relatively high risk of complications, including severe complications such as perforation,

occlusion of rectum, retroperitoneal hematoma, and Furnier’s gangrene[11-16]. During

the DGHAL-RAR procedure all sutures are placed under direct visual control, so risk of

misaligned sutures is greatly reduced. Additionally, during stapler-based procedures a

continuous ring of mucosa is being cut out, while in DGHAL-RAR longitudinal stripes of

untouched mucosa between the RAR sutures reduce the risk of impairment of anorectal

function and sensation. Conventional surgical hemorrhoidectomy according to Milligan

Morgan, Ferguson, and their modifications represent the most effective treatment method

of HD that is currently available. However, the effectiveness of these methods is limited

by various complications such as sphincter dysfunction (in up to 25% of patients), recto-

anal coordination impairment due to partial resection of anal mucosa (another 10% of

patients), postoperative bleeding or infection up to 5–15% of patients[15]. Also

postoperative recovery usually lasts from a few days to 2 weeks. Therefore, taking all

these facts into consideration, new methods of treatment like DGHAL and RAR, aside

from enhancing effectiveness, concentrate on preserving natural anatomical and

histological structure of anorectal region as much as on possibility to prevent from

anorectal function impairment. They are also aimed at shortening of pos t procedure

recovery[28, 29].

It is said that hemorrhoidal plexus is responsible for 15-20% of resting anal pressure.

According to some studies[17-19], these pressures are significantly higher in patients

with HD compared to healthy individuals, and drop after surgical management of HD

regardless of chosen method (Barron, Milligan-Morgan, Longo) was also reported[17, 18,



8

20]. Some authors even raise a question if elevated resting anal pressure is secondary to

swelling of hemorrhoidal cusions, or if it is an etiological factor of hemorrhoidal

disease[17]. On the other hand, many other authors state, that there was no significant

change in manometric findings in patients treated for hemorrhoidal disease[21-23]

leaving the question of initially raised pressure unanswered. Papers concerning the

DGHAL method also report no significant changes in basal and squeeze pressures[23].

Our study shows a significant drop in resting anal pressure after RAR, with coexistent

minor influence of the RAR procedure on squeeze anal pressure, although we have no

proof if the pressures were elevated initially as compared to healthy individuals. There is

still a need for a complex study involving an age and gender matched control group of

healthy individuals for comparison or perhaps a large scale prospective trial, to answer

this question.

The clinical results of the Recto-Anal Repair procedure are very promising, as most of

the patients were satisfied with the outcome, although the observation period of 12

months is too short to conclude the long-term effectiveness of the procedure. Moreover,

many of the patients treated with this method in our Department didn’t complete full

follow-up visits plan, so clinical results in those patients are unknown. It can be only

guessed that most of them didn’t have any symptoms after the treatment, and so didn’t

find visiting a doctor necessary. In short-term studies concerning stapler-based techniques

the recurrence rates were lower than in our analyzed group of patients[24-27].

DGHAL/RAR however may offer better safety profile and lower risk of anorectal

disturbances. Additionally, recovery after RAR procedure was much quicker compared to

classical Milligan-Morgan or Ferguson hemorrhoidectomy[4].





Conclusion



Recto-Anal Repair seems to be a safe method of treatment of IIIrd and IVth grade

hemorrhoidal disease with no major complications and a high rate of good short term

results. The procedure has a significant influence on resting and squeeze anal pressure,

with no evidence of risk of fecal incontinence after the operation. It remains to be

answered if that is a result of return to normal anal tone or should be considered as an

adverse effect. However, this is a preliminary study with small series of patients and short

follow-up time, so it is difficult to assess long-term efficacy, recurrence rates and long-

term influence on anorectal function, which still need to be assessed in larger studies with

longer follow-up period and bigger groups of patients.



9

Disclosures



Drs. P. Walega, M. Romaniszyn, J. Kenig, R. Herman, W. Nowak have no conflicts of

interest or financial ties to disclose.









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10

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